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

Catalog Number	420916
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).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
It was reported that there was a problem with the trumach tibia cutting guide when passing the saw.The guide split in two.There was no visible defect before use.The tibial cutting procedure with the broken trumach was interrupted at 3/4 of the procedure.The surgeon finalized the cut freehand using the line already drawn.However, there were no consequences for the patient, no remaining debris or changes in the slope of the cut or the tibial varus/valgus.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, ¿we had a problem with the trumach tibia cutting guide when passing the saw.He split in two.There was no visible defect before use.The intervention was able to continue normally.¿ the device associated with this report was returned to depuy synthes for evaluation.Photos were provided for review.See attachment (re_ (b)(4) pb trumach valence).Visual examination of the device and review of the photographic evidence confirmed the reported event.The trumatch ct cut guide kit r has broken in two pieces.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: 00054225 and no non-conformances or manufacturing irregularities were identified potential cause for the reported event can be attributed to off label use since it was reported that the saw blade used in surgery was: strycker sagital blade ref 6118-127-090/ cut dept: 90.0mm/material thickness: 1.27mm/cut edge:18.0mm.According to surgical technique dsus/jrc/1114/0591 rev.3, the resection must be performed with a 1.19 mm whale tail saw blade.The overall complaint was confirmed as the observed condition of the trumatch ct cut guide kit r would contribute to the complained device issue.Based on the investigation findings, potential can be attributed to off label use and 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 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: 00054225 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: 00054225 and no non-conformances or manufacturing irregularities were identified.
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.

• Brand Name: TRUMATCH CT CUT GUIDE KIT R
• Common Device Name: TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• 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: 17728060
• Report Number: 1818910-2023-18466
• Device Sequence Number: 15063002
• Product Code: OOG
• UDI-Device Identifier: 10603295384861
• UDI-Public: 10603295384861
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/12/2023

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 Expiration Date: 12/31/2023
• Device Catalogue Number: 420916
• Device Lot Number: 00054225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 09/29/2023; 09/29/2023; 10/16/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 10/01/2023; 10/09/2023; 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SAWBLADE (STRYCKER)
• Patient Sex: Unknown