|
|
| Device Problem
Unintended Movement (3026)
|
| Patient Problem
Failure of Implant (1924)
|
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
(b)(6) date of event: unknown.This report is for an unknown quantity of unknown screws/unknown lots.Part and lot number are unknown; udi number is unknown.Although implant records were provided with part numbers, we are unable to determine which screws broke, which screws became loose and which screws remained intact.The patient was implanted with the following screws on (b)(6) 2013 for the right pilon fracture: 3.5 mm locking screws (part 212.111, lot unknown, quantity 1); product code/common name: ktt/appliance, fixation, nail; additional product code: jds; 510k: k072095, 3.5 mm locking screws (part 212.112, lot unknown, quantity 1); product code/common name: ktt/appliance, fixation, nail; additional product code: jds; 510k: k072095, 3.5 mm locking screws (part 212.115, lot unknown, quantity 2); product code/common name: ktt/appliance, fixation, nail; additional product code: jds; 510k: k072095, 3.5 mm locking screws (part 212.119, lot unknown, quantity 2); product code/common name: ktt/appliance, fixation, nail; additional product code: jds; 510k: k072095, 3.5 mm locking screws (part 212.121, lot unknown, quantity 1); product code/common name: ktt/appliance, fixation, nail; additional product code: jds; 510k: k072095, 2.0 mm cortex screws (part 201.375.97, lot unknown, quantity 2); product code/common name: hrs/plate, fixation, bone; 510k: k063049, 4.0 mm cannulated screws (part 207.638, lot unknown, quantity 2); product code/common name: hwc/screw, fixation, bone; 510k: k963192, 4.0 mm cannulated screws (part 207.640, lot unknown, quantity 2); product code/common name: hwc/screw, fixation, bone; 510k: k963192, 3.5 mm cortex screws (part 204.814, lot unknown, quantity 1); product code/common name: hwc/screw, fixation, bone; additional product codes: hrs, jds; 510k: k131186, 3.5 mm cortex screws (part 204.816, lot unknown, quantity 5); product code/common name: hwc/screw, fixation, bone; additional product codes: hrs, jds; 510k: k131186, 3.5 mm cortex screws (part 204.826, lot unknown, quantity 1); product code/common name: hwc/screw, fixation, bone; additional product codes: hrs, jds; 510k: k131186, 3.5 mm cortex screws (part 204.832, lot unknown, quantity 1); product code/common name: hwc/screw, fixation, bone; additional product codes: hrs, jds; 510k: k131186, 3.5 mm cortex screws (part 204.836, lot unknown, quantity 1); product code/common name: hwc/screw, fixation, bone; additional product codes: hrs, jds; 510k: k131186, 3.5 mm cortex screws (part 204.840, lot unknown, quantity 1); product code/common name: hwc/screw, fixation, bone; additional product code: jds; 510k: k112583.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is an attorney.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
| |
|
Event Description
|
|
Patient was involved in a motorcycle accident in (b)(6) 2013 and sustained a left sacrum fracture, left anterior pubic ramus fracture, open grade 2, right pilon fracture (distal tibia fracture) and left proximal humerus fracture.Patient underwent the following treatment on (b)(6) 2013: left sacrum fracture - closed reduction and percutaneous screw placement.Left anterior pubic ramus fracture - open reduction and internal fixation and irrigation and debridement of open fracture.Right pilon fracture - closed reduction with external fixator application.Left proximal humerus fracture - closed reduction.The patient was implanted with a synthes 7.3 mm cannulated screw with corresponding washer, synthes 3.5 mm pelvic recon plates, stainless steel and another manufacturer¿s external fixator.(stryker hoffman three external fixator).During surgery on (b)(6) 2013 two punctate lacerations were noted, one was approximately 1 cm and the second was approximately 2 cm in the inguinal region of the left leg.There was draining from these two punctate type incisions.The one larger incision communicated directly by way of soft tissue to the anterior pubic ramus on the left side.No gross contamination or particular matter visualized the wound.Wound was irrigated with copious amounts of saline.All necrotic material was debrided using metzenbaum scissors.There was an iliopectineal disruption at the fracture site.It advances comminution noted at the anterior pubic ramus.The plate was fashioned after the pelvis was reduced onto the anterior internal aspect of the ileum to the anterior aspect of the pelvis.Several cortical screws were then thrown achieving rigid internal fixation of the anterior hemipelvis.Fluoroscopic images were taken on (b)(6) 2013.The screw was measured and placed with a washer.Rigid internal fixation noted.Fluoroscopic images taken again confirming appropriate position of the hardware and screw placement.Closed reduction of the pilon fracture ¿ two 5.0 mm schanz pins were then placed in the tibial diaphysis.A third pin was placed through the calcaneus into the medial and lateral using fluoroscopic imaging.Carbon fiber rods were attached to the external fixator pins.X-rays of pilon taken.The pin sites were wrapped in sterile 2-inch kling wrap and hibiclens sterile soak.Patient had soft tissue swelling of the extremities with some fracture blisters over the medial side which precluded an immediate internal fixation of the fracture.Secondary to the fracture blisters and soft tissue swelling, the patient needed staged reconstructive management of the right pilon.The left shoulder was then palpated and placement of fracture fragment was noted.Patient previously underwent reduction of the shoulder at beside under fluoroscopic imaging.The fracture fragments were adhesed.The patient had an unstable three part of proximal humerus fracture that required an open reduction and internal fixation at a later date.The patient had significant amount of blood loss (800 ml) from anterior approach of the pelvis as such his proximal humerus fracture to undergo staged reconstruction.Patient¿s postoperative condition was stable.Patient required 48 hours of iv antibiotics post-surgery for the open fracture protocol.It was recommended that patient not weight bear on left side for 4 weeks to 8 weeks.For radiographic images of inferior pubic ramus fractures.Patient needed fixation for right femur with proximal humerus fracture.On (b)(6) 2013, the external fixator was removed and patient underwent right pilon open reduction internal fixation and left ulna fracture open reduction internal fixation.Patient was implanted with synthes 3.5 mm anterolateral distal tibial plate, 4.0 mm cannulated screws as lag screws and synthes 3.5 mm lcdc plate in the ulna.The procedure began with removal of external fixator on right lower extremity.Esmarch used to exsanguinate the right lower extremity.A fracture blister on the anterior aspect of the right tibia which had resolved, there was still some skin issues on the medial flap and tibia.Several 4.0 mm cannulated screws were utilized as lag screws across the fracture receiving rigid internal fixation of the joint space.A 2.0 mm locking mini-frag plate was placed along the anterior cortex of the provisional fixation and cortex along the anterior tibia.Soft tissue attachment was kept to each fragment.The anterolateral plate of 3.5 mm cortical locking screws were then placed.Final fluoroscopic images were taken.A cannulated screw was placed to achieve a lag screw fixation across the fracture.Five (5) cc of dbx was placed with bone graft.Patient¿s left lower extremity was placed in a short leg splint.There was small articular cartilage removed from an unknown area.After inspection of the talus that showed that there was a large 2 x 3 cm articular cartilage defect in the anterolateral unspecified area that the patient most likely need at the time.A 3.5 mm lcdc plate was fashioned over the volar surface of ulna and applied in compression mode achieving rigid internal fixation and compression.Final fluoroscopic images were taken.Patient¿s postoperative condition was stable.Patient had a follow up office visit on (b)(6) 2015 and it was noted that patient was seen in the emergency room on (b)(6) 2015 for right ankle and foot pain which patient states had onset approximately two weeks prior to emergency room (er) visit.Pain started at heel and now feels the pain is generalized about the ankle.Denies any recent trauma or injury only prolonged walks and playing with grandkids.Describes pain when placing weight on ankle and the foot which worsens throughout day.Pain is relieved when he utilizes fracture boot with weight bearing.Radiographs and computed tomography scan showed no acute findings and patient was told to follow up.Reportedly, patient was told in the er that the hardware was loose and states the pain level is the same as when he presented to the er whenever he attempts to ambulate with full weight or out of the fracture boot, but pain is improved when he ambulates with the fracture boot or keeps his weight off of the extremity.Patient has decreased sensation at the right foot (medial and lateral aspect of the foot and first intermetatarsal webspace which is baseline secondary to history of trauma to the right lower extremity.X-rays and ct taken on (b)(6) 2015 showed single screw fracture noted which appears stable and there is no lucency noted about the screw.Right ankle post-traumatic stress osteoarthrosis.Surgeon recommended ankle fusion (total ankle arthroplasty) as treatment for this.Ct and x-rays taken of right foot on (b)(6) 2015 revealed soft tissue swelling with some subcutaneous edema and skin thickening.Fracture site not completely healed and there is some attempted osseous bridging.Many of the screws are fractured and have some lucency surrounding them.Could be secondary to chronic loosening although infection would look identical.Soft tissue swelling.Ct and x-rays taken of right ankle on (b)(6) 2015 revealed for the tibia ¿ there is a sequela of prior hardware fixation of a distal tibial fracture.Long lateral plate affixed with multiple screws.A couple of screws are fractured.Fixation with a smaller plate from an anterior approach.Many of these screws have some surrounding lucency adjacent to them as well.A couple of the medial malleolar screws are fractured as well.Fibula: remote and healed distal fibular fracture.Soft tissue: soft tissue swelling of patient¿s distal calf and ankle that could be dependent edema although cellulitis would look similar.There is significant lucency around many of the screws near the ankle joint, many of the screws are fractured.Additionally, the tibial fracture is partially healed with some dysmorphic attempted osseous bridging and pseudoarthrosis formation at this site.X-rays taken of right ankle on (b)(6) 2015 revealed remote cortical plate and screw fixation of the distal tibia with healed fracture deformity.One of the distal tibial screws is fractured and slightly separated.The more medial of the 2 distal tibial subarticular screws demonstrates mild surrounding lucency which may be related to loosening.Healed fracture deformity of the distal fibula.Screw tracts in the mid tibial diaphysis and calcaneus.Soft tissue swelling at the ankle.X-rays taken of complete foot right on (b)(6) 2015 revealed bone density decreased.Remote orif distal tibia with a fractured screw.Right ankle and foot obtained in the er on (b)(6) 2015 revealed a long anterolateral fixed angle blade plate and smaller anterior plate about the distal tibia fracture.Screws both proximally and distally appear to have fractured.There is no lucency or evidence of loosening about the hardware.There is a nonunion with sclerotic borders appreciated about the right distal tibia fracture site.The tibiotalar joint reveals mild osteoarthrosis.Follow up office visit on (b)(6) 2016, patient admits to right lower leg and ankle pain.Upon inspection of right lower extremity, there are multiple well healed surgical incisions over the distal tibia with a long anterior incision.Mild edema is appreciated about the distal tibia and ankle.The patient admits to tenderness to palpation over the nonunion site about the anterior aspect of the distal tibia.Range of motion evaluation of the right ankle reveals dorsiflexion to 10 degrees past neutral and plantar flexion to 30 degrees without discomfort.Inversion is to 10 degrees and eversion is to 5 degrees.Upon stress of the nonunion, there is movement appreciated.The patient is able to flex and extend the hallux and lesser toes.Patient reports decreased sensation over the dorsum of the foot.Patient required a revision open reduction internal fixation with iliac crest stem cell implantation, bone morphogenic protein and a tibial plateau autograft.Patient underwent removal of hardware from the right distal tibia on (b)(6) 2016.Tibia, fibula osteotomy for correction of varus internal rotation and recurvatum deformity of the distal tibia.Autogenous bone graft harvest from the right iliac crest.Open reduction internal fixation of the right tibia nonunion and osteotomy.Patient presented with long-standing right tibia nonunion.Patient had been utilizing the nonunion without pain and then developed pain.The pain interfered with his ability to ambulate.Patient had degenerative joint disease (djd) of the right ankle and perhaps the pain generator.Biopsies obtained at the time of surgery and good correction of the patient¿s deformity as the patient walked with varus and internal rotation.It was felt that realignment should aid in the treatment of the arthritic ankle and if union achieved would decrease pain.Patient still has posttraumatic degenerative arthritis of the ankle.Patient had reactive soft tissue changed and cultures were obtained of the periosteum in the nonunion site.There was significant reactive tissue at the distal aspect of the plate, but there was obvious mobility at this site and this most likely reactive tissue secondary to the inflammatory response from bone resorption and motion of the plate and bone interface.Patient had a large area of attenuated soft tissue coverage and the surgeon performed a soft tissue transfer over the anterior aspect of the leg to allow for excellent coverage.Elevation of the flap was part of the procedure.This was a posterior tibial artery based flap.Doppler used to identify where the anastomosis was probably made.Removal of hardware ¿ patient¿s flap retracted and distal plate identified.The screws were backed out.There was 1 broken screw that was later removed.There were 2 crossing screws in the medial aspect that were not removed because this would have caused undue tension on the soft tissue.The proximal plate screws were removed and then the plate was backed out.Tibia-fibula osteotomy: motion at the nonunion site was noted, but it was difficult to mobilize.Once realignment was achieved of the osteotomy and a resection of soft tissue performed about the nonunion site, bone graft was harvested.Bmp was mixed and then at the nonunion site after fixation, the autogenous bone graft was placed with bmp.Internal fixation of osteotomy: a long t-plate was utilized mainly for the posterior aspect of the tibia.It was bent to allow for increased external rotation.The saw cut was then made to resect the anterior crest of the tibia to decrease prominence of the plate.The plate was secured with a proximal screw, then the locking screws distally, followed by additional proximal locking screws.Two interfragmentary screws were used across the nonunion site prior to plating distally.Patient seen for follow up evaluation on (b)(6) 2016, status post right distal tibia open reduction internal fixation for nonunion on (b)(6) 2016.Patient complains of edema round ankle.The patient is in wheelchair and cast was removed.The ankle has discoloration and edema, common for this stage in the postoperative period.Three views of the right ankle taken on (b)(6) 2016 revealed the anatomic alignment of the distal tibia with secure retained hardware.Progress in healing.Syndesmosis and ankle mortise were reduced.Concomitant devices reported: 3.5 mm lcp® metaphyseal plate 7 holes (part 223.407, lot unknown, quantity 1); demineralized bone matrix (dbx) (part/lot unknown, quantity 1).This report is for an unknown quantity of unknown screws that loosened.This is report 2 of 2 for (b)(4).
|
| |
|
Manufacturer Narrative
|
|
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
| |
|
Event Description
|
|
On (b)(6) 2016, the patient was still suffering from severe pain in the ankle, that the patient could only able to ambulate in a fracture boot, as walking in normal shoes caused too much pain.The surgeon¿s plan was to remove the failed hardware and perform a revision orif.However, because of the increased scar tissue at the anterior aspect of the tibia and the length of the incision, increased risk of the incision from the revision surgery not healing became a concern.So, the surgeon called in a plastic surgeon to perform a flap procedure.On (b)(6) 2016, the patient was seen for preoperative evaluation and complained of pain in the right ankle.On (b)(6) 2016, the patient presented to the clinic for a postoperative evaluation.Reportedly, the patient experienced some anterior iliac crest pain secondary to the bone graft harvest.
|
| |
|
Manufacturer Narrative
|
|
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
| |
|
Manufacturer Narrative
|
|
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: event description and concomitant devices updated : without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
| |
|
Search Alerts/Recalls
|
|
|
