MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRUMATCH CT PIN GUIDE KIT R; DRILL GUIDES

Model Number 420579

Device Problems Computer Software Problem (1112); Patient-Device Incompatibility (2682)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

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

Patient plan did not align with patient anatomy, per sales rep.

Manufacturer Narrative

Product complaint #
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> (b)(4) investigation summary
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> an investigation confirmed the reported event.The issue was escalated per pie-1999025.Capa-10805 has been initiated.Nr-0164326 has been initiated for all affected lots.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot
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> the investigation has found a coding error in the trumatch v3 software that caused the virtual alignment of the anatomical markers on the series of ct scans by the segmentation software not to occur.The result is incorrectly dimensioned instrument sets (cutting guides, pinning guides and surgical plans) that do not correctly align the leg.The error in the software occurred in update from v2 to v3 of the siemens segmentation fast 3d which was implemented on (b)(6)-2021.

Manufacturer Narrative

Product complaint # (b)(4).Updated medical device problem code.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.

Manufacturer Narrative

Product complaint # (b)(4).Corrected date received by manufacturer (g3) for (b)(4) to (b)(6) 2022.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: an investigation confirmed the reported event.The issue was escalated per (b)(4).Capa-10805 has been initiated.(b)(4) has been initiated for all affected lots.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot: the investigation has found a coding error in the trumatch v3 software that caused the virtual alignment of the anatomical markers on the series of ct scans by the segmentation software not to occur.The result is incorrectly dimensioned instrument sets (cutting guides, pinning guides and surgical plans) that do not correctly align the leg.The error in the software occurred in update from v2 to v3 of the siemens segmentation fast 3d which was implemented on 26-april-2021.

• Brand Name: TRUMATCH CT PIN GUIDE KIT R
• Type of Device: DRILL GUIDES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12240988
• MDR Text Key: 263959361
• Report Number: 1818910-2021-16359
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295430803
• UDI-Public: 10603295430803
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420579
• Device Catalogue Number: 420579
• Device Lot Number: 27332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1818910-08/05/2021-005-R
• Patient Sequence Number: 1
• Patient Sex: Female