MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP*2 FEMORAL IMPACTOR; KNEE INSTRUMENT : IMPACTORS

Model Number 96-6180

Device Problems Device Slipped (1584); Material Twisted/Bent (2981); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2018

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

Sterile processing department would like to replace 3 large and 3 small calcar planers.They had not been replaced and are dull.There was no mention of this in a procedure that i was a part of.A sterile processing lead also requested that 2 old pfc sigma femoral impactors and 2 old specialist 2 tibial impactors be replaced.The bolt that connects the black femoral impactor to the metal adaptor is loose and the bolt is stripped.The tibial impactors have been used for trial revision trays and are scraped and worn from impacting the trials.

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: the device associated with the reported event was not returned for examination.The investigation could not verify or draw any conclusions about the reported event without the device to examine.The investigation findings did not indicate that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.

• Type of Device: KNEE INSTRUMENT : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9792524
• MDR Text Key: 184523272
• Report Number: 1818910-2020-06893
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295247203
• UDI-Public: 10603295247203
• 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
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96-6180
• Device Catalogue Number: 966180
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1