MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.6MM KIRSCHNER WIRE WITH 5MM THREAD-TROCAR POINT 150MM; BONE PLATE

Model Number 292.71

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 02/21/2017

Event Type  Injury  

Manufacturer Narrative

Additional product code: ktt.Complainant part is not expected to be returned for manufacturer review/ investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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

It was reported that on (b)(6) 2017, the patient underwent an open reduction and internal fixation of right olecranon nonunion with distal radius autograft, removal of right radial head prosthetic secondary to loosening, revision right radial head arthroplasty and removal of failed tension band construct.The implants removed were synthes radial head prosthetic and tension band wire construct wherein two (2) k-wires were loose.On (b)(6) 2016, after sustaining a fall which resulted in an olecranon and comminuted radial head fracture, the patient underwent an open reduction and internal fixation of olecranon fracture and endo-prosthetic replacement of the proximal radius.The patient was implanted with a synthes radial head and stem.Post-operatively, the patient had improvement but started noting worsening pain and issues with her hardware.On (b)(6) 2016, the patient underwent a partial removal of the exposed hardware from the tension band wiring but was not fully removed since there was no concern for infection.On (b)(6) 2017, during a doctor's visit, the patient continues to report that she is back to doing all of her normal activities without restrictions.She is having only occasional discomfort in cold weather, but this is completely tolerable.This is 1 of 2 for report (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.

Manufacturer Narrative

Product complaint # (b)(4).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

6/8/2020: updated event description: it was reported that on (b)(6) 2017, the patient underwent an open reduction and internal fixation of right olecranon nonunion with distal radius autograft, removal of right radial head prosthetic secondary to loosening, revision right radial head arthroplasty and removal of failed tension band construct.Both posterior k wires backout significantly.There is significant lysis around the stem of the radial head prosthesis.The implants removed were synthes radial head prosthetic and tension band wire construct wherein two (2) k-wires were loose.On (b)(6) 2016, after sustaining a fall which resulted in an olecranon and comminuted radial head fracture, the patient underwent an open reduction and internal fixation of olecranon fracture and endo-prosthetic replacement of the proximal radius.The patient was implanted with a synthes radial head and stem.On (b)(6) 2016, the patient underwent a partial removal of the exposed hardware from the tension band wiring but was not fully removed since there was no concern for infection.On (b)(6) 2017, the radiograph demonstrate evidence of proximal olecranon fracture fragment pullout from the plate and screw construct.The plate fixation is still in good position other than this fracture pullout.Radial head prosthesis remains in position but there is approximately 3 mm of gapping between the radial head prosthesis and the capetillium.On (b)(6) 2017, the patient underwent a revison open reduction and internal fixation of failed nonunion of the right olecranon and deep hardware removal.Acumed olecranon plate with screws were removed and were replaced with a synthes 4-hole variable angle olecranon plate and synthes 2.0 mm 5-hole small fragment plate.On (b)(6) 2017, during a doctor's visit, the patient continues to report that she is back to doing all of her normal activities without restrictions.She is having only occasional discomfort in cold weather, but this is completely tolerable.On (b)(6) 2019, patients return for follow-up of her right elbow.More recently she has noticed some mild discomfort along the dorsal/posterior aspect of the elbow and forearm in the previous incision and hardware.Examination of the right elbow demonstartes evidence of a fully healed posterior incision without concern for infection.There is evidence of more defined contour to the olecranon and hardware given patients weight loss.Minimal tenderness along the incision discomfort she has been noting is likley secondary to the hardware itself.Given her weight loss, there is less soft tissue in the region and she is noticing this more.However on reviews of her xrays, there is no concern for failure.The patient understandably does not wish to proceed with hardware removal as it is significantly bothersome enough.This complaint involves four (4) devices.Additional information under : under medical history : procedure history l5-s1 interlaminar epidural steroid injection ((b)(6) 2019).On (b)(6) 2014: bilateral hand numbness and weakness , paresthesia , urinary incontinence , back pain (lumbosacral spine) , muscle weakness , neck stifness.On (b)(6) 2019 pain in left wrist that is worse with motion , abrasion in left lower extremity , constipation ((b)(6) 2019) , abdominal pain and distention ((b)(6) 2019) , nausea ((b)(6) 2019).On (b)(6) 2020 worsening low back pain , l2-l5 severe right-sided foraminal stenosis , lumbar pain.Medications: naproxen sodium (aleve) 220 mg capsule ((b)(6) 2020) , cholecalciferol, vitamin d3, 10mcg ((b)(4)unit) tablet ((b)(6) 2020) , diazepam (valium) 5mg tablet (100 mg by mouth).2.Under relevant lab test : mri of the lumbar spine ((b)(6) 2018) , xr lumbar spine 4 or 5 vw ((b)(6) 2020) ,mri outside image storage ((b)(6) 2019) ,xr wrist complete left ((b)(6) 2019) ,or c-arm imaging ((b)(6) 2019).

Manufacturer Narrative

Product complaint # (b)(4).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

6/4/2020: 03/06/2020: updated event description: it was reported that on (b)(6) 2017, the patient underwent an open reduction and internal fixation of right olecranon nonunion with distal radius autograft, removal of right radial head prosthetic secondary to loosening, revision right radial head arthroplasty and removal of failed tension band construct.Both posterior k wires backout significantly.There is significant lysis around the stem of the radial head prosthesis.Underwent partial removal od the wire but not full removal as there was no concern for infection.The implants removed were synthes radial head prosthetic and tension band wire construct wherein two (2) k-wires were loose.On (b)(6) 2016, after sustaining a fall which resulted in an olecranon and comminuted radial head fracture, the patient underwent an open reduction and internal fixation of olecranon fracture and endo-prosthetic replacement of the proximal radius.The patient was implanted with a synthes radial head and stem.On (b)(6) 2017 radiograph demonstrate evidence of proximal olecranon fracture fragment pullout from the plate and screw construct.The plate fixation is still in good position other than this fracture pullout.Radial head prosthesis remains in position but there is approximately 3 mm of gapping between the radial head prosthesis and the capetillium.-options for this failure: second surgery to either perform a bony fragments excision and triceps advancement versus revision orif with a plate construct that will be able tp curve more over the posterior aspect of this olecranon to gain further fixation.Patient would like to proceed with revision orif of the olecranon.Post-operatively, the patient had improvement but started noting worsening pain and issues with her hardware.On (b)(6) 2016, the patient underwent a partial removal of the exposed hardware from the tension band wiring but was not fully removed since there was no concern for infection.On (b)(6) 2017, during a doctor's visit, the patient continues to report that she is back to doing all of her normal activities without restrictions.She is having only occasional discomfort in cold weather, but this is completely tolerable.On (b)(6) 2019, patient's return for follow-up of her right elbow.More recently she has noticed some mild discomfort along the dorsal/posterior aspect of the elbow and forearm in the previous incision and hardware.Examination of the right elbow demonstrates evidence of a fully heated posterior incision without concern for infection.There is evidence of more defined contour to the olecranon and hardwardware given patients weight loss.Minimal tenderness along the incision discomfort she has been noting is likely secondary to the hardware itself.Given her weight loss, there is less soft tissue in the region and she is noticing this more.However on reviews of her xrays, there is no concern for failure.This complaint involves four (4) devices.This report is 3 of 4 for report (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.H10 additional narrative: b6: updated tests/lab data.B7: updated medical history.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.H6: patient code 3191 is used to capture additional medical/surgical intervention required and medical device removal.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.

• Brand Name: 1.6MM KIRSCHNER WIRE WITH 5MM THREAD-TROCAR POINT 150MM
• Type of Device: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9834961
• MDR Text Key: 183706460
• Report Number: 2939274-2020-01285
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 20886982180862
• UDI-Public: (01)20886982180862
• Combination Product (y/n): N
• PMA/PMN Number: K971987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 292.71
• Device Catalogue Number: 292.71
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2020
• Patient Sequence Number: 1
• Treatment: 1.6MM KRSNER WRE W/ 5MM THRD-TROCR PNT 150MM.; 2.5MM KIRSCHNER WIRE W/TROCAR POINT 285MM.; 22MM COCR RDAL HEAD STNDRD HGT/12.5MM-STRL.; 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE.
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR