MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PERCUTANEOUS ARM 255MM; FORCEPS

Model Number	398.754
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is j&j sales consultant.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 an (b)(6) 2020,during routine inspection, a percutaneous arm and a hohmann-style arm buttons on the side for the release to attach to the handle does not function.There was no patient involvement.Concomitant device reported: handle (part # unknown, lot # unknown, quantity 1).This report is for 1 percutaneous arm 255mm.This is report 2 of 2 for complaint (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: the device has been 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.
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, h4, h6: part #: 398.754, synthes lot number: 10-5992, supplier lot number: 10-5992, release to warehouse date: 03-jun-2010, supplier: (b)(4).Visual inspection: the percutaneous arm 255mm (part # 398.754/ lot # 10-5992) was received at us customer quality (cq).Upon visual inspection, it was observed that the device had surface wear consistent with normal use.Besides cosmetic scratches/nicks, there were no visual defects to note.Functional test: the mating sliding mechanism was not returned so the returned arm was not able to be mounted, however, it was identified that the screw/spring within the proximal end of the complaint device was jammed.No damage or defect was found relating to the arm release button.Due to the jammed condition of the spring/screw, the overall complaint could be confirmed as the arm would not assemble or disassemble/disengage as designed.Can the complaint be replicated with the returned device(s)? unable to perform.Dimensional inspection: dimensional inspection was not performed as device disassembly to access relevant components was not possible.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Conclusion: the overall complaint was confirmed for the received percutaneous arm 255mm as the spring/screw component was jammed.Although no definitive root-cause could be determined, the internal components of the device may have galled together.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 preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: PERCUTANEOUS ARM 255MM
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10063600
• Report Number: 2939274-2020-02362
• Device Sequence Number: 3514702
• Product Code: HTD
• UDI-Device Identifier: 10886982201584
• UDI-Public: (01)10886982201584
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2020

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: 398.754
• Device Catalogue Number: 398.754
• Device Lot Number: 10-5992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Initial Date Received by Manufacturer: 05/02/2020
• Supplement Date Received by Manufacturer: 05/19/2020; 07/01/2020
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 05/29/2020; 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - HANDLES: TRAUMA