MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM

Model Number 399.99

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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 Description

It was reported that on (b)(6) 2020, during an unknown surgery the reduction forceps with serrated jaw-rachet broke.Fragments generated from broken device and was removed easily.There is no surgical delay.Procedure was successfully completed.Patient status is satisfactory.This complaint involves one (1) reduction forceps with serrated jaw-ratchet 144mm this is report 1 of 1 for (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.Additional narrative: a product investigation was conducted: investigation flow: damage visual inspection: the reduction forceps with serrated jaw-ratchet 144mm (p/n: 399.99, lot number: t182520) was received at us cq.Upon visual inspection, it was observed that one of the serrated jaws was broken at its distal tip, and the broken fragment was not received at us cq.No other issues were identified with the returned components of the device.The device failure/defect is identified.Dimensional inspection: no dimensional inspection was performed due to the post-manufacturing damage.Document/specification review: no design issues or discrepancies were identified.The complaint is confirmed.Investigation conclusion: this complaint is confirmed as the as received condition of the reduction forceps with serrated jaw-ratchet 144mm (p/n: 399.99, lot number: t182520) showed a broken serrated jaw at the distal tip.No definitive root cause could be attributed to this allegation.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.Device history lot part number: 399.99 lot number: t182520 manufacturing site: tuttlingen.Release to warehouse date: may 13, 2019.A review of the device history records was performed for the finished device lot number, and no non-conformance's were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.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: REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10636085
• MDR Text Key: 210031659
• Report Number: 2939274-2020-04522
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982203175
• UDI-Public: (01)10886982203175
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/12/2020

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
• Device Operator: Health Professional
• Device Model Number: 399.99
• Device Catalogue Number: 399.99
• Device Lot Number: T182520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Initial Date Manufacturer Received: 09/12/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 10/14/2020
• Supplement Dates FDA Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1