MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMBINATION BENDING/CUTTING PLIERS F/1.0MM - 2.0MM PLATES; PLIERS,SURGICAL

Model Number	391.965
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is synthes sales consultant.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.
Event or Problem Description
It was reported that on (b)(6) 2019, the combination bending/cutting pliers prong that pushes against both grip handles is snapped off.This was not used during the case but just recognized during pre-op.There was no patient involvement.This report is for one (1) combination bending/cutting pliers f/1.0 mm - 2.0 mm plates.This is report 1 of 1 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.Part: 391.965; lot: a7ma08; manufacturing site: tuttlingen; release to warehouse date: week 08, 2003.A review of the device history records is not possible; the device history record (dhr) is no longer available due to the age of the instrument (over 16 years old).Service & repair evaluation: the customer reported the combination bending/cutting pliers prong that pushes against both grip handles is snapped off.The repair technician reported the compression spring is broken and missing parts.Damaged component is the reason for repair.The cause of the issue is unknown.The following parts were replaced: spring screw, compression spring with roller and combination bending/ cutting.The item was repaired per the inspection sheet, passed synthes final inspection, and will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore 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.
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.D4: it was noted the synthes lot number is 4562685 and the supplier lot number is a7ma08.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: COMBINATION BENDING/CUTTING PLIERS F/1.0MM - 2.0MM PLATES
• 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: 8800037
• Report Number: 2939274-2019-59245
• Device Sequence Number: 3294783
• Product Code: HTC
• UDI-Device Identifier: 10887587041032
• UDI-Public: (01)10887587041032
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/24/2019

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
• Operator of Device: Health Professional
• Device Model Number: 391.965
• Device Catalogue Number: 391.965
• Device Lot Number: 4562685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 07/26/2019; 08/21/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/16/2019; 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1