MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R; TIBIAL KNEE FLEX INSERT

Catalog Number	02.12.0210FR
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 01 april 2019: lot 183041: (b)(4) items manufactured and released on 28-jun-2018.Expiration date: 2023-06-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event additional implant involved: batch review performed on 03 april 2019: gmk-sphere 02.07.1202r tibial tray fixed cemented size 2 r lot.(k090988), lot 186206: 110 items manufactured and released on 22-nov-2018.Expiration date: 2023-11-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
During the primary knee surgery and while attempting to engage the 10mm insert screw with the tibial tray, it was discovered that screw would not engage.An 11mm insert was opened and the screw from that insert was used in the 10mm insert with no issues.This caused a 2-minute delay in the case and the surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R
• Common Device Name: TIBIAL KNEE FLEX INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8478383
• Report Number: 3005180920-2019-00220
• Device Sequence Number: 14049509
• Product Code: JWH
• UDI-Device Identifier: 07630030826146
• UDI-Public: 07630030826146
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2019

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 Expiration Date: 06/17/2023
• Device Catalogue Number: 02.12.0210FR
• Device Lot Number: 183041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 04/03/2019
• 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