MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE OFFSET CONNECTOR 5 MM

Model Number	02.07.0005
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed by regulatory affairs department on 3 june 2020: lot 145743a: (b)(4) items manufactured and released on 11 october 2019.Expiration date: 2024-09-24.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been sold without any similar reported event.Other device involved in the event: gmk hinge 02.07.10.9641 offset adapter 5mm lot 1856269.Batch review performed by medacta regulatory affairs department on 24 june 2020: lot 1856269: (b)(4) items manufactured and released on 16 january 2019.No anomalies found related to the problem.To date, no similar events reported on items of the same lot.
Event or Problem Description
When trying to assemble the offset onto the tibia, the offset does not come out of the instrument (offset adaptor), it stays in there and doesn't connect to the tibia.This has happened a few times and following the surgical technique correctly.Due to this case additional anesthesia was necessary and the surgery was prolonged of 10 minutes.
Additional Manufacturer Narrative
Visual inspection performed by medacta r&d knee project manager: during the visual inspection to the internal o-ring and the three fixation teeth have been found damaged.However, these damages cannot be related to the failure of the implant offset insertion, whose cause remains unknown.Since we do not have the 5 mm implant offset available for evaluation and, since the 5 mm trial offset can be properly connected, we can not establish the real cause of the failure during the surgery.(the internal profile and surfaces of the offset connector and there are no visible signs of wear).

• Brand Name: GMK-HINGE OFFSET CONNECTOR 5 MM
• Common Device Name: OFFSET CONNECTOR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10189421
• Report Number: 3005180920-2020-00349
• Device Sequence Number: 16370932
• Product Code: JWH
• UDI-Device Identifier: 07630030815607
• UDI-Public: 07630030815607
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K102437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 09/24/2024
• Device Model Number: 02.07.0005
• Device Catalogue Number: 02.07.0005
• Device Lot Number: 145743A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2020
• Supplement Date Received by Manufacturer: 05/25/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Weight: 85