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

Model Number	42-0907
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: TRUMATCH INSTRUMENTS : FIXATION PINS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11265884
• Report Number: 1818910-2021-02248
• Device Sequence Number: 3132096
• Product Code: JWH
• UDI-Device Identifier: 10603295384823
• UDI-Public: 10603295384823
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

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
• Operator of Device: Health Professional
• Device Model Number: 42-0907
• Device Catalogue Number: 420907
• Device Lot Number: 25258
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1