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

Model Number 03.118.111

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during hardware removal in the ankle due to infection on (b)(6) 2020, the end part of the silicone handle with rotating cap was broken and spinning.The issue happened when the surgeon hit the reported device with a hammer and screwdriver.They loss the broken part but they just found it and just collected it.A torque limiting screwdriver handle was used to continue with the case.The issue did not slow the surgery down.The procedure was completed and there was no impact on the patient.Concomitant device reported: unknown hammer (part # unknown, lot # unknown, quantity unknown), unknown screwdriver (part # unknown lot # unknown, quantity 1) this report is for one (1) silicone handle/quick coupling w/ rotating cap.This is report 1 of 1 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H3, h6: part number: 03.118.111, lot number: t995391, manufacturing site: tuttlingen, release to warehouse date: 14-mar-2014.No ncrs were generated during production review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The repair technician reported the device needed an adjustment and passed all visual and operating tests.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 19-nov-2020 and will be returned to the customer upon completion of the service and repair process.Finalized service record will be archived in 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 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
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10958982
• MDR Text Key: 220174616
• Report Number: 2939274-2020-05471
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982073686
• UDI-Public: (01)10886982073686
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2020

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
• Device Operator: Health Professional
• Device Model Number: 03.118.111
• Device Catalogue Number: 03.118.111
• Device Lot Number: T995391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 12/22/2020; 12/22/2020
• Supplement Dates FDA Received: 12/22/2020; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - SCREWDRIVERS: SHAFTS