MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREW AND PLATE HOLDING FORCEPS

Model Number	347.985
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned device is not able to hold screws because one of the distal screw holding tips has broken off.The returned device was manufactured in 2016.Review of the device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition.No product design issues or discrepancies were observed during this investigation.The thickness of the distal forcep tip on the returned device near breakage measured 1.00mm which is within specification.The raw material certificate and hardening protocols was confirmed to meet the specification of the device with no relevant non-conformance noted.A definitive assignable root cause for the device breaking could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.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 history lot, part number: 347.985, synthes lot number: t133205, manufacture site: (b)(4), part expiration date: n/a, list of nonconformance¿s: nr-0036109.Further review of the device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition.The raw material certificate and hardening protocols was confirmed to meet the specification of the device with no relevant non-conformance noted.Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent an orthopedic procedure.During the procedure, a cannulated hexagonal screwdriver does not engaged on the screw head properly and a holding forceps for cortex screws does not hold items properly.Procedure was successfully completed with two (2) minutes surgical delay.No patient consequence.Concomitant device reported: unknown - screws: trauma (part # unknown, lot # unknown, quantity 1).This report is for one (1) screw and plate holding forceps.This is report 2 of 2 for (b)(4).

• Brand Name: SCREW AND PLATE HOLDING FORCEPS
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8600680
• Report Number: 2939274-2019-57961
• Device Sequence Number: 16662705
• Product Code: HTD
• UDI-Device Identifier: 10886982193629
• UDI-Public: (01)10886982193629
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2019

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: 347.985
• Device Catalogue Number: 347.985
• Device Lot Number: T133205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 05/10/2019
• Patient Sequence Number: 1