MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US REPL TIP FEMORAL HD IMPACTOR; EXTREMITY INSTRUMENTS : IMPACTORS

Model Number 2001-66-000

Device Problems Material Deformation (2976); Material Twisted/Bent (2981); Scratched Material (3020)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 09/24/2020

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

Staff have indicated femoral impactor head tips have been ¿warped¿ and scratched due to wear and tear and no longer articulate with the femoral trial heads properly.Items are no longer functional.Items have been discarded and no lot # available.No further information is available.No intra-op or patient issues.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.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.

• Brand Name: REPL TIP FEMORAL HD IMPACTOR
• Type of Device: EXTREMITY INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10622129
• MDR Text Key: 209653277
• Report Number: 1818910-2020-21537
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295080138
• UDI-Public: 10603295080138
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2001-66-000
• Device Catalogue Number: 200166000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1