MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRUMATCH CT FEM CUT TIB PIN R; TRUMATCH INSTRUMENTS : FIXATION PINS

Model Number 42-0907

Device Problem Incorrect Measurement (1383)

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

Event Date 01/01/2021

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

During bilateral tka, there was a major issue with the external rotation on both femoral blocks.The blocks were externally rotated.After noticing there was too much external rotation, surgeon had to use the regular sizing device to dial it back down to normal, delaying each knee by about 10 minutes.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned for evaluation.No evidence was found indicating product error was a contributing factor to the reported event.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot : a device history record (dhr) review was performed.The review found one non-conformance (nr-0138283) against the provided lot number.The nr was for a batch of resin not meeting a material specification, and it is not related to the current reported event of too much external rotation in surgery.

• Brand Name: TRUMATCH CT FEM CUT TIB PIN R
• Type of Device: TRUMATCH INSTRUMENTS : FIXATION PINS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11265884
• MDR Text Key: 229860706
• Report Number: 1818910-2021-02248
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295384823
• UDI-Public: 10603295384823
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42-0907
• Device Catalogue Number: 420907
• Device Lot Number: 25258
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1