MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US FEM/TIB EXTRAC 11X7 3/4 IN; KNEE INSTRUMENT : EXTRACTION INSTRUMENTS

Model Number 2421-02-000

Device Problem Break (1069)

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

Event Date 08/31/2020

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

Voluntary report was received under mw5097975.It was reported that while attempting to hammer out a femoral implant during an orthopedic surgical procedure, distal end of the osteotome broke off, flew up and struck the overhead light and landed back on the surgical table.

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 : 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.

• Brand Name: FEM/TIB EXTRAC 11X7 3/4 IN
• Type of Device: KNEE INSTRUMENT : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11057574
• MDR Text Key: 225593623
• Report Number: 1818910-2020-27545
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295122722
• UDI-Public: 10603295122722
• 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: 12/08/2020

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: 2421-02-000
• Device Catalogue Number: 242102000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1