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 Problems Break (1069); Naturally Worn (2988); Illegible Information (4050)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2020

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

It was reported that the handle fractured, all fractured pieces recovered.Nothing left in patient and no surgical delay.

Event Description

Additional information was received stating that the lot number is worn down and difficult to read, this was a best attempt to read and provide the number.

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.

• 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: 10726534
• MDR Text Key: 212723643
• Report Number: 1818910-2020-23186
• 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,Followup
• Report Date: 10/08/2020

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: 10/08/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 10/21/2020; 12/01/2020
• Supplement Dates FDA Received: 10/27/2020; 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1