MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US P.F.C.* PRESS-FIT ROD WRENCH; KNEE INSTRUMENT : WRENCHES

Model Number 86-5189

Device Problem Material Twisted/Bent (2981)

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

Event Date 01/01/2021

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

It was reported that the reamer adapters looked stripped.The revision femoral/tibial sleeve clamp and the pfc press-fit wrench were worn down.No patient involvement.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: examination of the returned device confirmed the reported event.The noted damage is consistent with excessive torque being used.And the investigation did not establish a need for corrective action.Depuy synthes considers, the investigation closed.Should additional information be received, the information will be reviewed.And the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material, that would be a contributing factor in the reported allegation(s) where the lot code was provided.A manufacturing records evaluation (mre) was not performed.

Event Description

Additional information was received, stating that the tips were worn down on the clamp parts.

• Type of Device: KNEE INSTRUMENT : WRENCHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11531981
• MDR Text Key: 243704016
• Report Number: 1818910-2021-05629
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 10603295216759
• UDI-Public: 10603295216759
• 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
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86-5189
• Device Catalogue Number: 865189
• Device Lot Number: H0402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1