MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SILICONE HANDLE/QUICK COUPLING W/ ROTATING CAP; FORCEPS

Model Number	03.118.111
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was 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) 2020, during distal fibula surgery using variable angel (va) ankle system, one (1) 2.0mm drill bit broke and one (1) screwdriver handle was damaged.The drill bit 2.0mm broke during drilling of proximal screw and the broken drill shaft was retained in drill.The broken drill tip fell onto the floor, a new drill bit was selected and the procedure continued without incident.The screwdriver handle's rotating cap broke off during use.The surgeon continued use of screwdriver without incident.There were two (2) minutes of surgical delay.Fragments were easily removed.The procedure was successfully completed.Patient outcome as planned.Concomitant device reported: unk - drill (part# unknown; lot# unknown; quantity: 1).This report is for one (1) silicone handle/quick coupling w/ rotating cap.This is report 2 of 2 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.H10 additional narrative: h3, h6: investigation summary service and repair history: the previous service event for part number 03.118.111 with lot number(s) t981683 has been reviewed.The customer called in a service request for this item on dec 30, 2020 for broken 2.0mm drill bit and one (1) damaged screwdriver handle.The item was previously returned for service on sep 27, 2013 due to missing quick coupling sleeve.The previous service condition of missing quick coupling sleeve is not relevant to the current complained issue of broken 2.0mm drill bit and one (1) damaged screwdriver handle.The manufacture date of this item is jan 18, 2013.The service history review is unconfirmed.Service and repair evaluation: the screwdriver handle rotating cap broke off during use, broken rotating cap placed on back table and the surgeon continued use of screwdriver without incident.The repair technician reported the instrument was disassembled.Adjustment needed is the reason for repair.The cause of the issue is unknown.The item was repaired per the inspection sheet, passed synthes final inspection on jan 19, 2021 and will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 30.Finalized service record will be archived in tungsten document management system.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 history lot a shr was performed on the serviceable device and it was found that the device was manufactured on jan 18, 2013.A manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure 100673626 no manufacturing record evaluation is required.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: SILICONE HANDLE/QUICK COUPLING W/ ROTATING CAP
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11224460
• Report Number: 2939274-2021-00440
• Device Sequence Number: 4238895
• Product Code: HTD
• UDI-Device Identifier: 10886982073686
• UDI-Public: 10886982073686
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2020

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
• Operator of Device: Health Professional
• Device Model Number: 03.118.111
• Device Catalogue Number: 03.118.111
• Device Lot Number: T981683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.0MM DRILL BIT/QC/125MM; UNK - DRILL
• Patient Age: 17 YR