MAUDE Adverse Event Report: DEPUY IRELAND 9616671 TRUMATCH ATTUNE KIT RIGHT; TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES

Catalog Number 420946

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2017

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

It was reported that the femoral resection block broke during resection.The saw blade will be included with blocks and be returned.

Manufacturer Narrative

Product complaint # (b)(4).

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the returned device confirmed the reported event.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TRUMATCH ATTUNE KIT RIGHT
• Type of Device: TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7163624
• MDR Text Key: 96347201
• Report Number: 1818910-2018-50167
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295431800
• UDI-Public: 10603295431800
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 420946
• Device Lot Number: 088JU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 12/12/2017; 02/19/2018
• Supplement Dates FDA Received: 01/09/2018; 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR