MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRUMATCH CT CUT GUIDE KIT R; TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES

Model Number 420916

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 09/03/2021

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

We had an attune trumatch case with one of the consultants had femur done and tibia half done.When the consultant resected the tibia on the lateral side then moved across to the medial and continued the resection, the guide snapped in half.All pieces were accounted for and removed.There was no surgery delay.It did not affect the patient as the resection was almost complete and the remainder of the block was still pinned in place.

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.

Event Description

Additional information received, indicated that there was a 2-minute delay.While they checked, the parts were all accounted for.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the reported device was not returned.Examination of the provided photographs confirmed the reported event.No evidence was found indicating product error was a contributing factor to the reported event.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 no manufacturing deviations or non-conformances were noted.

• Brand Name: TRUMATCH CT CUT GUIDE KIT R
• Type of Device: TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12529053
• MDR Text Key: 273349226
• Report Number: 1818910-2021-20949
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295384861
• UDI-Public: 10603295384861
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 420916
• Device Catalogue Number: 420916
• Device Lot Number: 27618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1