MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN PIN GUIDES; DRILL GUIDES

Model Number	420579
Medical Device Problem Codes	Computer Software Problem (1112); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Patient plan did not align with patient anatomy, per sales rep.
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.H10 additional narrative: 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 = > the device associated with the reported event was not returned for evaluation.An investigation confirmed the reported event.The issue was escalated per pie-1999025.Capa-10805 has been initiated.(b)(6) 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.
Additional Manufacturer Narrative
H7 and h9: recall information provided.

• Brand Name: UNKNOWN PIN GUIDES
• Common Device Name: 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: 12240933
• Report Number: 1818910-2021-16358
• Device Sequence Number: 12113134
• Product Code: NJL
• UDI-Device Identifier: 10603295430803
• UDI-Public: 10603295430803
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/21/2021

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 Model Number: 420579
• Device Catalogue Number: UNK PIN GUIDES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 07/21/2021; 10/19/2021; 10/20/2021; 02/28/2024
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 08/12/2021; 10/19/2021; 10/21/2021; 03/20/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1818910-08/05/2021-005-R
• Patient Sequence Number: 1
• Patient Sex: Male