MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 TRUMATCH CT CUT GUIDE KIT R; TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES

Catalog Number	420916
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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.
Event or Problem Description
Surgeon has had a number of trumatch cases where the blocks are under-resecting by several mm's even factoring in the sawblade thickness.Trumatch is necessitating repeated recuts.Both himself and the rep claim that he is getting a good fit with his blocks on the bone each time and spend significant time ensuring this and yet the blocks under-resect.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received: a.What was the exact allegation against the device? was it worn, cracked, broken into pieces, bent, stripped, cross threaded or any device interaction? no damage to the device.Device seemed to under-cut the bone relative to what it was planned and designed to do.The trumatch blocks are a single use bespoke resection guide created off patient specific ct scans by the trumatch team in warsaw.B.Was there a surgical delay? if yes, what is the duration of the delay? delay created by having to re-cut the bone with conventional instruments.
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.H10 additional narrative: added: d4, g4 pma/510(k); corrected: d1, d2a, d2b.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).Investigation summary : surgeon has had a number of trumatch cases where the blocks are under-resecting by several mm's even factoring in the sawblade thickness.Trumatch is necessitating repeated recuts.Both himself and the rep claim that he is getting a good fit with his blocks on the bone each time and spend significant time ensuring this and yet the blocks under-resect.The device associated with this report was not returned to depuy synthes for evaluation.The investigation could not confirm the reported event.A product development investigation was performed and it was concluded that the segmentation is designed within trumatch specifications and no issues were identified.A manufacturing record evaluation was performed for the finished device product description: trumatch ct cut guide kit r product code: 420916 lot number: tmk00073677 and no non-conformances or manufacturing irregularities were identified.The overall complaint was not confirmed for trumatch ct cut guide kit r.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 complaint condition.As part of depuy synthes 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.Device history lot : a manufacturing record evaluation was performed for the finished device product description: trumatch ct cut guide kit r product code: 420916 lot number: tmk00073677 and no non-conformances or manufacturing irregularities were identified.Device history review : a manufacturing record evaluation was performed for the finished device product description: trumatch ct cut guide kit r product code: 420916 lot number: tmk00073677 and no non-conformances or manufacturing irregularities were identified.

• Brand Name: TRUMATCH CT CUT GUIDE KIT R
• Common Device Name: TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19228780
• Report Number: 1818910-2024-09684
• Device Sequence Number: 6980272
• Product Code: OOG
• UDI-Device Identifier: 10603295384861
• UDI-Public: 10603295384861
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/02/2024
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 07/31/2024
• Device Catalogue Number: 420916
• Device Lot Number: 00073677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 05/06/2024; 05/31/2024; 07/03/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 05/23/2024; 06/04/2024; 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown