MAUDE Adverse Event Report: DEPUY IRELAND 9616671 RECLAIM BOLT TORQ WRENCH HNDL; RECLAIM INSTRUMENTS : WRENCHES

Catalog Number 297500300

Device Problems Break (1069); Device-Device Incompatibility (2919); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint : (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

There is a combination of four instruments that were damaged during this case.It was discovered that these items were damage while putting them back together in sterile processing following the case.There were no delays during the actual case.The first two instruments that were damaged or the disassembly a tool threaded cap, and the disassemble a torque shaft 75 mm.There is a thread on the threaded cap that is stripped and the 75 mm torque shaft cannot be removed from the threaded cap.The second set of instruments that were damaged that work together or the bolt torque wrench handle in the bolt torque wrench body.The t handle that attaches to the bolt torque wrench handle broke off of that device and cannot be found in sterile processing.However, there is still a portion of the bolt torque wrench handle that is attached to the bolt torque wrench body and cannot be removed.No surgical delay.

Manufacturer Narrative

(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.Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the reported observation.The root cause is attributed to device design.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up 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.H10 additional narrative: product complaint(b)(4).Investigation summary : examination of the returned instrument confirmed the reported observation.The root cause is attributed to device design.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: RECLAIM BOLT TORQ WRENCH HNDL
• Type of Device: RECLAIM INSTRUMENTS : WRENCHES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8655301
• MDR Text Key: 146543366
• Report Number: 1818910-2019-94838
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 10603295155898
• UDI-Public: 10603295155898
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 297500300
• Device Lot Number: A0111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR