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

Model Number	391.962
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 unknown date the carbide cutting/bending pliers were reported to have the carbide chipped off.There was no patient and surgical involvement.This report is for one (1) bending/cutting pliers.This is report 1 of 1 for (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: part number: 391.962, lot number: t185966, manufacturing site: tuttlingen, release to warehouse date: 22-nov-2019.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the bending/cutting pliers (p/n: 391.962, lot #: t185966) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the carbide inserter on one of the jaw was broken.No other issues were observed with the returned device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Bending/cutting plier.Complaint confirmed? yes, the device received was broken.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the bending/cutting pliers (p/n: 391.962, lot#: t185966).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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: BENDING/CUTTING PLIERS
• Common Device Name: PLIERS, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11777433
• Report Number: 2939274-2021-02223
• Device Sequence Number: 19617621
• Product Code: HTC
• UDI-Device Identifier: 10886982198525
• UDI-Public: 10886982198525
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

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: 391.962
• Device Catalogue Number: 391.962
• Device Lot Number: T185966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1