MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SLIDING MECHANISM; FORCEPS

Model Number 314.291

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.(b)(4).  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

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the plastic handle of the sliding mechanism broke during manipulation.The surgery was delayed two minutes but completed successfully.There were no patient consequences.This is report 1 of 1 for (b)(4).

Event Description

It was reported that the alternative instrument was used to complete the procedure.Concomitant device reported: unknown guide wire ( part# unknown, lot# unknown, 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.The incorrect rec'd by mfr date was inadvertently utilized in initial medwatch.The correct date is november 12, 2019.  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.H3, h6: part: 314.291, lot: 170257-102, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: november 02, 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: visual inspection of the returned device performed at customer quality (cq) shows the black polyamide handle is broken at the attachment screw.Both screws which are holding the handle are still in place, remaining within the instrument.The inserts are also missing.The broken off handle piece was returned.The received condition does agree with the complaint description for broken and is confirmed.Dimensional inspection: dimensional analysis around the broken part of the handle and returned broken piece could not be measured accurately due to post manufacturing damages.Document specification the following documents were reviewed as part of this investigation: collinear reduction clamp handle review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Conclusion: no definitive root cause could be determined; it is more likely that unintended excessive forces such as device being dropped during usage/handling contributed to this complaint condition.During the investigation, no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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: SLIDING MECHANISM
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9410193
• MDR Text Key: 195103775
• Report Number: 2939274-2019-62472
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982188779
• UDI-Public: (01)10886982188779
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2019

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
• Device Operator: Health Professional
• Device Model Number: 314.291
• Device Catalogue Number: 314.291
• Device Lot Number: 170257-102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: 12/23/2019; 01/03/2020
• Supplement Dates FDA Received: 12/23/2019; 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN GUIDE WIRE; UNKNOWN GUIDE WIRE