MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BENDING/CUTTING PLIERS; PLIERS,SURGICAL

Model Number 391.962

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is synthes 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 Description

It was reported that on an unknown date, the tip of the bending /cutting pliers was broken.It is unknown if there was patient involvement.  this report is for one (1) bending /cutting pliers this is report 1 of 1 for complaint (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.H11: corrected data: g4: awareness date reported on follow up 1 report as august 19, 2019 but should have been september 16, 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.H10: additional narrative e3: reporter is synthes sales consultant.Investigation summary: part number: 391.962, lot number: a7ea21, manufacturing site: tuttlingen, release to warehouse date: week 21, 1995.A review of the device history records is not possible, the dhr is no longer available due to the age of the instrument (over 24 years old).The bending/cutting pliers (p/n: 391.962 lot: a7ea21) was received showing significant wear and scratches along the instrument.The carbide inserts on the serrated jaws were worn, nicked, and gouged.A portion of the carbide on one of the jaws was broken off, the broken off fragment(s) was not returned.Dimensional inspection: dimensional inspection was not conducted as the carbide inserts/relevant features could not be disassembled for inspection, post manufacturing damage, and as the device is over 24 years old, the broken condition was likely not due to a manufacturing/design issue.The visual wear and scratches were visually confirmed.Document/specification review: the drawings, reflecting the manufactured and current revision, were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed for the bending/cutting pliers (p/n: 391.962 lot: a7ea21) as a portion of the carbide on one of the jaws was broken off.The instrument was also scratched, and the remaining serrated jaws carbide inserts were worn and nicked.While no definitive root cause could be determined for the broken carbide, it is possible that the device encountered unintended forces and/or the condition was due to consistent use over the part¿s lifetime (24+ years).During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: BENDING/CUTTING PLIERS
• Type of Device: PLIERS,SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9071024
• MDR Text Key: 158690329
• Report Number: 2939274-2019-60593
• Device Sequence Number: 1
• Product Code: HTC
• UDI-Device Identifier: 10886982198525
• UDI-Public: (01)10886982198525
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 391.962
• Device Catalogue Number: 391.962
• Device Lot Number: A7EA21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Date Manufacturer Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1