MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US FEMORAL EXTRACTOR; KNEE INSTRUMENT : EXTRACTION INSTRUMENTS

Model Number 2588-87-000

Device Problems Material Deformation (2976); Naturally Worn (2988)

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

Event Type  malfunction  

Manufacturer Narrative

(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

Two damaged items at (b)(6) hospital: damaged posterior augment ref (b)(4) ¿ no longer sits in femoral trial securely.Worn femoral punch ref (b)(4) ¿ distal tip is mis-shapen and worn down and no longer fit for purpose.Identified by (b)(6).

Event Description

Unfortunately the hospital no longer have the items so i¿m unable to send across the lot numbers.

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 no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: FEMORAL EXTRACTOR
• Type of Device: KNEE INSTRUMENT : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12554316
• MDR Text Key: 274066964
• Report Number: 1818910-2021-21553
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295148036
• UDI-Public: 10603295148036
• 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,Followup
• Report Date: 09/23/2021

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: 2588-87-000
• Device Catalogue Number: 258887000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 09/30/2021
• Supplement Dates Manufacturer Received: 10/04/2021; 10/25/2021
• Supplement Dates FDA Received: 10/04/2021; 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1