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

Catalog Number	420580
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/23/2019
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
It was reported that the trumatch guide set the femur in varus, but it was noticed in case and corrected with traditional instruments.No surgical delay.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
There was an approximately 5 minutes delay.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.No evidence was found indicating product error was a contributing factor to the reported event.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot: 17747.Device history review: dhr has been reviewed, nonconformance was noted.Nonproduct nr was reviewed by qe and has no impact on complaint.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TRUMATCH CT PIN GUIDE FEM L
• Common Device Name: DRILL GUIDES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8695780
• Report Number: 1818910-2019-95888
• Device Sequence Number: 14118951
• Product Code: NJL
• UDI-Device Identifier: 10603295430810
• UDI-Public: 10603295430810
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2019

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: 420580
• Device Lot Number: 17747
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 06/12/2019; 07/08/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 06/17/2019; 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR