MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM L; KNEE TIBIAL INSERT

Catalog Number	02.12.0313FL
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 31-july-2019: lot 180391: (b)(4) items manufactured and released on 17-may-2018.Expiration date: 2023-04-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
During the primary knee surgery, and while the surgeon was attempting to tighten the poly insert with the torque limiting screw driver, it was observed that the screw that came with the 3x13 poly would not tighten.A 3x12 poly was opened to use the screw to complete the case.There was a 2-minute delay in the case and the surgery was completed successfully.
Additional Manufacturer Narrative
On the (b)(6) the sales representative reported that the devices are no longer available.
Event or Problem Description
On the (b)(6) the sales representative reported that the devices are no longer available.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM L
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8925183
• Report Number: 3005180920-2019-00704
• Device Sequence Number: 2128353
• Product Code: JWH
• UDI-Device Identifier: 07630030862571
• UDI-Public: 07630030862571
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• 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,Followup
• Report Date (Section B): 11/12/2019

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: 04/25/2023
• Device Catalogue Number: 02.12.0313FL
• Device Lot Number: 180391
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 11/12/2019
• 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