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

Model Number	420578
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
The following problem occurred during the implantation of the knee prosthesis: after correct placement of the femoral trumach template, the femoral receiving surface was formed.The probe stopped at 6 mm on the suprapatellar surface.Because of this, we had to resize, and by reshaping the femoral surface, we were able to glue 2 numbers smaller prostheses with security.In this size the prosthesis rested well but unfortunately due to the size reduction they also had to adjust the size of the tibial tray.
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).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: examination of the returned device could not confirm the reported event.No evidence was found indicating product error was a contributing factor to the reported event.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot : a device history record (dhr) review was performed.The review found one non-conformance (nr-0138283) against the provided lot number.The nr was for a batch of resin not meeting a material specification, and it is not related to the current reported event of a sizing issue.Corrected: h3, h5.
Additional Manufacturer Narrative
Product complaint # = >(b)(4) investigation summary = > update 20-jan-2022: the investigation was re-opened upon receipt of post-op x-rays.Examination of the returned device and provided x-ray images could not confirm the reported event.No evidence was found indicating product error was a contributing factor to the reported event.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot = > a device history record (dhr) review was performed.The review found one non-conformance (nr-0138283) against the provided lot number.The nr was for a batch of resin not meeting a material specification, and it is not related to the current reported event of a sizing issue.

• Brand Name: TRUMATCH CT PIN GUIDE KIT L
• Common Device Name: DRILL GUIDES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11056043
• Report Number: 1818910-2020-27456
• Device Sequence Number: 14172092
• Product Code: NJL
• UDI-Device Identifier: 10603295430797
• UDI-Public: 10603295430797
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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,Followup
• Report Date (Section B): 12/08/2020

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: 420578
• Device Catalogue Number: 420578
• Device Lot Number: 25027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 01/04/2021; 01/21/2021; 03/01/2021; 01/20/2022
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/13/2021; 01/28/2021; 03/01/2021; 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2020
• 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