|
|
| Device Problems
Device Dislodged or Dislocated (2923); Unintended Movement (3026)
|
| Patient Problems
Pain (1994); No Code Available (3191)
|
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
Device was used for treatment, not diagnosis.Patient age, dob and weight not provided for reporting.Date of event: unknown.This report is for an unknown screw/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.The initial reporter of this event is the patient.(b)(4).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.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
| |
|
Event Description
|
|
It was reported that a patient underwent a revision of one (1) wrist fusion plate and ten (10) screws on (b)(6) 2018 due to one (1) unknown screw backing out, and three (3) unknown screws out of the initial construct breaking and causing a lot of pain to the patient.The patient initially underwent a wrist fusion surgery to implant the initial wrist fusion plate and screw construct in (b)(6) 2017 when they injured their wrist.Subsequently, after about six months from then, the patient described that they did not feel good and were in pain, hence went for a follow-up visit during which, multiple x-rays taken during which confirmed that multiple screws had broken.Hence, the patient underwent a revision procedure on (b)(6) 2018.It was realized that the heads of three (3) screws were broken from the shafts, and the shafts were retained in the patient.The backed out screw was removed intact.All other screws and the wrist fusion plate were removed intact as well.The procedure took about two and a half hours to complete.The surgeon revised the patient to an unknown plate and screw construct and implanted bone graft from the hip in the wrist.The patient still feels a lot of post-operative pain due to the hip surgery and is still in cast.The patient will visit the surgeon again for a post-operative follow-up on (b)(6) 2018, when the surgeon plans to unwrap the cast.This complaint involves two (2) devices.Concomitant devices reported: unknown screws (part# unknown, lot# unknown, quantity# 6); wrist fusion plate (part# 02.110.150, lot# unknown, quantity# 1).This report is 1 of 2 for (b)(4).
|
| |
|
Manufacturer Narrative
|
|
Patient weight is now known.Actual date of implantation is now known.Corrected data: event description includes all data known to date.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 underwent a left wrist-arthrodesis along with a thumb cmc (carpometacarpal) arthroplasty on (b)(6) 2017.Radiographs taken on (b)(6) 2017 in the clinic during a follow-up showed breakage of one (1) distal screws in the left wrist plate, but maintained alignment across the arthrodesis site.After examination, the surgeon allowed the patient a release to return to work without restrictions starting the next day.During a post-operative follow-up on (b)(6) 2018, the surgeon realized that the patient had swelling distally at the distal extent of the plate and the extensor tendons to the index and long finger run right over the site of the swelling.The patient also was starting to get some discomfort with resisted finger extension.Radiographs taken on the same day showed atrophic nonunion of the patient¿s left wrist arthrodesis with screw breakage and loss of fixation distally.The distal portion of the plate was also realized to be quite prominent, both on radiographs and clinically.This is when the patient decided to undergo a revision arthrodesis with iliac crest bone graft.The surgeon believed that the patient was fully compliant.The patient medical records showed that an unknown quantity of screws broke, but the patient reported a total of three (3) screws broke.Concomitant devices reported: unknown screws (part # unknown, lot # unknown, quantity # 6), lcp wrist fusion standard bend plate (part # 02.110.150, lot # unknown, quantity # 1).This report is for an unknown trauma screw.This report is 2 of 3 for (b)(4).
|
| |
|
Manufacturer Narrative
|
|
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
|
|
It was reported that a patient underwent a left wrist-arthrodesis along with a thumb cmc (carpometacarpal) arthroplasty on (b)(6) 2017.Radiographs taken on (b)(6) 2017 in the clinic during a follow-up showed breakage of one (1) distal screws in the left wrist plate, but maintained alignment across the arthrodesis site.After examination, the surgeon allowed the patient a release to return to work without restrictions starting the next day.During a post-operative follow-up on (b)(6) 2018, the surgeon realized that the patient had swelling distally at the distal extent of the plate and the extensor tendons to the index and long finger run right over the site of the swelling.The patient also was starting to get some discomfort with resisted finger extension.Radiographs taken on the same day showed atrophic nonunion of the patient¿s left wrist arthrodesis with screw breakage and loss of fixation distally.The distal portion of the plate was also realized to be quite prominent, both on radiographs and clinically.This is when the patient decided to undergo a revision arthrodesis with iliac crest bone graft.The surgeon believed that the patient was fully compliant.The patient medical records showed that an unknown quantity of screws broke, but the patient reported a total of three (3) screws broke.On (b)(6) 2018, the patient underwent the revision surgery.During this surgery, the surgeon identified that almost all the screws attached to the previously implanted wrist fusion plate were broken at the screw head-neck junction.Three screw shafts were reported to be retained in the patient¿s metacarpal.Two of these were removed using a needle driver to back them out manually.The plate was also removed.Inspection of the attempted wrist arthrodesis site showed nonunion with gross motion throughout the site, particularly after the hardware removal.The patient was then reportedly revised to one (1) competitor's 2.5 mm trilock total wrist fusion plate with five (5) gold 2.5 mm cortex bone screws and eight (8) blue 2.5 mm locking screws.The surgery was completed successfully without any complications.The patient was reportedly taken to the recovery room in a stable condition.This complaint involves an unknown quantity of devices.Concomitant devices reported: screws (part unknown, lot unknown, quantity unknown); locking compression plate (lcp) wrist fusion standard bend plate (part 02.110.150, lot h259228, quantity 1).
|
| |
|
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.Patient height reported as 5 feet 10 centimeters.Additional patient id: (b)(6).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.Customer quality conducted a review of the provided photographs.Background: three unknown screws were reported with a complaint condition of ¿broken (2+ pieces): postoperatively : rm¿ and one unknown screw was reported with a complaint condition of ¿migration/backout/pull-out : rm.¿ however, the devices were not returned for investigation; only pictures were provided.Thus, the following investigation is based on the picture provide this investigation addresses the one screw reported for back out.Device condition: the provided pictures show a plate (part 02.110.150 | lot h259228), four (4) cortex screws, and four (4) locking screws.Of these devices, two (2) locking screws and one (1) cortex screw were noted as broken.The breaks are each transverse and located as the base of the screw head.In each instance the threaded portion was not shown.The plate, two (2) intact locking screws, and three (3) intact cortex screws showed wear consistent with use and which would not impact the functionality.It is unknown which of these screws was the screw which reportability backed out.No defects were identified in the provided image.Thus, as no issues were identified and x-rays were not provided displaying the back out condition, the complaint condition for this device could not be confirmed and could not be replicated.Lot number review: a dhr review could not be performed as the lot number is unknown.Drawing review/risk assessment: a drawing review or risk assessment review could not be completed as it is unknown which screw part/family backed out.Also, as the physical device was not received no further dimensional or material testing could be completed.Conclusion: a visual inspection via the provided images was performed as part of this investigation.The complaint condition could not be confirmed from the provided information as no defect relating to back out was observed in the images, no x-rays were provided, and the physical device was not returned.No new malfunctions were observed during the course of this investigation.From the provided information, no design or manufacturing issue was identified.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 patient identifier: (b)(6), patient age and date of birth.Date of implant reported only as (b)(6) 2017, exact date is not known 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.Event description, concomitant devices this report is for one (1) unknown screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.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
|
|
It was reported that a patient underwent a revision of one (1) locking compression plate (lcp) wrist fusion standard bend plate and ten (10) screws on (b)(6) 2018 due to one (1) unknown screw backing out, and two (2) unknown screws out of the initial construct breaking and causing a lot of pain to the patient.The patient initially underwent a wrist fusion surgery in (b)(6) 2017.Subsequently, after about six months from then, the patient reported not feeling well and was in pain.During a follow up visit on unknown date, x-rays confirmed that multiple screws had broken.Patient underwent a revision procedure on (b)(6) 2018.It was realized that the heads of two (2) screws were broken from the shafts, and the shafts were retained in the patient.The backed out screw was removed intact.All other screws and the plate were removed intact as well.The procedure took about two and a half hours to complete.The surgeon revised the patient to an unknown plate and screw construct and implanted bone graft from the hip in the wrist.The patient still feels a lot of post-operative pain due to the hip surgery and is still in a cast.The patient will visit the surgeon again for a post-operative follow-up on march 06, 2018, when the surgeon plans to unwrap the cast.Concomitant devices reported: screws (part number unknown, lot number unknown, quantity 7); lcp wrist fusion standard bend plate (part 02.110.150, lot h259228, quantity 1).
|
| |
|
Search Alerts/Recalls
|
|
|
