MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI END CAP WITH T40 STARDRIVE 0MM EXT F/TI TIBIAL NAILS-EX; NAIL,FIXATION,BONE

Model Number	04.004.000
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is jnj representative.The device was received, the investigation is in progress, 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 or Problem Description
It was reported that on (b)(6) 2021, an orthopedic procedure was performed for unknown reason.End cap would not thread onto nail.Replaced with a new end cap.The procedure was completed successfully and there was a surgical delay of 5 minutes.There was no patient consequence.Concomitant device reported: unknown screws (part# unknown; lot# unknown; quantity: unknown).This complaint involves two (2) devices.This report is for (1) ti end cap with t40 stardrive 0mm ext f/ti tibial nails-ex.This is report 1 of 2 (b)(4).
Additional 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.H3, h6: a product investigation was conducted.Visual inspection: the ti end cap with t40 stardrive 0mm ext f/ti tibial nails-ex (p/n: 04.004.000, lot number: h709142) was received at us cq.Visual inspection of the complaint device showed that the distal full thread was stripped functional test: a functional assessment was not performed with the complaint device since the applicable mating component (nail) was not returned.Dimensional inspection: length l1 was measured and found to be conforming per relevant drawing.Document/specification review: based on the date of the manufacturing the relevant current and manufacturing drawings were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the visual inspection of the complaint device revealed stripped distal thread.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: manufacturing location: supplier - (b)(4) / inspected and packaged by: monument.Manufacturing date: 26-oct-2018.Expiration date: 30-sep-2027.Part number: 04.004.000s, ti end cap /t40 strdiv 0mm ext-ster f/ti tibial nails-ex.Lot number: h709142 (sterile).Lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming and final inspection, met all inspection acceptance criteria.Certificate of compliance was reviewed and determined to be conforming.Packaging label log (pll) lppf rev e, lmd rev a was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn supplied by (b)(4) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.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: TI END CAP WITH T40 STARDRIVE 0MM EXT F/TI TIBIAL NAILS-EX
• Common Device Name: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11303908
• Report Number: 2939274-2021-00729
• Device Sequence Number: 20092778
• Product Code: JDS
• UDI-Device Identifier: 10886982083371
• UDI-Public: (01)10886982083371
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.004.000
• Device Catalogue Number: 04.004.000
• Device Lot Number: H709142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 03/15/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAILS; UNK - SCREWS: TRAUMA