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

Catalog Number	420915
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trumatch blocks broke.No further information is provided.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Additional 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.H11 additional narrative: added: a2 (age) and d9 corrected: d4 (primary udi number).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional 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 that 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 that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information was received and states that : customer "used a wider saw blade for this patient due to larger patient anatomy versus using the recommended whale tail blade.He was still able to complete the resections without any surgical delay and was pleased with patient outcome"."he is aware to use whale tale blade for future tmk cases".
Additional Manufacturer Narrative
Product complaint #:(b)(4).Investigation summary = > it was reported that the trumatch blocks broke.The product was returned to j&j medtech orthopaedics design team for evaluation.Visual inspection of the returned device revealed that the femur guide broke in zone 3, confirming the reported event.Additionally, the saw slot of the guide was "popped" out and was not seated correctly as a consequence of the thicker saw blade used during surgery.The observed damage was traced to user, as per the following information received by the customer: he "used a wider saw blade for this patient due to larger patient anatomy versus using the recommended whale tail blade.He was still able to complete the resections without any surgical delay and was pleased with patient outcome".Properly handling and¿attention to the approved use of the device diminishes the risk of failure.Please refer to the trumatch® personalized solutions - attune knee resection guide & pin guide systems surgical technique (rev.D, page 7) and associated ifu to review the proper handling and care for these devices, which states that a 1.19 mm whale tail saw blade needs to be used for the distal femoral resection.A product development investigation was performed and it was concluded that the proposal, the femur guide and the tibial guide were designed within trumatch specifications and no issues were identified.A manufacturing record evaluation was performed for the finished device with product code: 420915 case number: tmk00088929 product description: trumatch ct cut guide kit l, and no non-conformances or manufacturing irregularities were identified.The overall complaint was confirmed as the observed condition of the trumatch ct cut guide kit l would have contributed to the complained device issue.¿ based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.A manufacturing record evaluation was performed for the finished device with product code: 420915 case number: tmk00088929 product description: trumatch ct cut guide kit l, and no non-conformances or manufacturing irregularities were identified.A manufacturing record evaluation was performed for the finished device with product code: 420915 case number: (b)(4).Product description: trumatch ct cut guide kit l, and no non-conformances or manufacturing irregularities were identified.H11 additional narrative: corrected: h3.

• Brand Name: TRUMATCH CT CUT GUIDE KIT L
• Common Device Name: RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20609993
• Report Number: 1818910-2024-23061
• Device Sequence Number: 7411289
• Product Code: NJL
• UDI-Device Identifier: 10603295384854
• UDI-Public: (01)10603295384854(10)00088929
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K193540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

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 Catalogue Number: 420915
• Device Lot Number: 00088929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 11/12/2024; 12/09/2024; 12/16/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 11/13/2024; 12/12/2024; 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 95 KG