MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK EFFICIENCY TIBIAL OFFSET HANDLE; SURGICAL INSTRUMENT FOR KNEE

Catalog Number	11.01001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 20 march 2018 (b)(4).Investigation performed by r and d product manager on 21 march 2018.The retentive elastic connection of the tibial offset handle is broken at the level of the two lateral teeth.The breakage was caused probably due to excessive lateral force applied during searching for the best coverage.It is not clear if the breakage occurred with the trial insert in place on the tibia trial baseplate; if so, the constrain between femur and tibia could have stressed the handle while searching the best tibia coverage and the connection broke.
Event or Problem Description
During the trial reduction with trial components in place, while adjusting the tibial tray position for best coverage, the tibial handle suddenly disassembled from the tray.The tibial offset handle was broken.

• Brand Name: GMK EFFICIENCY TIBIAL OFFSET HANDLE
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7361000
• Report Number: 3005180920-2018-00167
• Device Sequence Number: 555136
• Product Code: LXH
• UDI-Device Identifier: 07630030877414
• UDI-Public: 07630030877414
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 03/22/2018

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 Expiration Date: 01/11/2023
• Device Catalogue Number: 11.01001
• Device Lot Number: 177001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 03/22/2018
• 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: 46 YR
• Patient Weight: 85