MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GENERAL SPHERE INSTRUMENT SET; INSTRUMENT FOR KNEE SURGERY

Model Number	11.01002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22november 2021.Lot 2107280 general mis sphere instrument set: (b)(4) items manufactured and released on 23-jun-2021.No anomalies found related to the problem.Expiration date: 2026-06-13.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.Gmk efficiency 77.11.0055 impactor handle lot.Mat38278: (b)(4) items manufactured.No anomalies were found related to the problem.To date, no other similar events have been reported on the same lot.
Event or Problem Description
When the surgeon was impacting the tibial keel punch, it was observed that the impactor handle broke.The surgeon spent 25-minutes removing the stuck keel punch from the proximal tibia and additional anesthesia was administered.The surgery was anyway completed successfully.The patient had a hard bone.

• Brand Name: GENERAL SPHERE INSTRUMENT SET
• Common Device Name: INSTRUMENT FOR KNEE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12852080
• Report Number: 3005180920-2021-00904
• Device Sequence Number: 4317260
• Product Code: LXH
• UDI-Device Identifier: 07630030882890
• UDI-Public: 07630030882890
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2021

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: 06/13/2026
• Device Model Number: 11.01002
• Device Catalogue Number: 11.01002
• Device Lot Number: 2107280
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male