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

Catalog Number	11.01001
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 07 march 2019: gmk sphere general set 11.01001, lot: 188651: (b)(4) items manufactured and released on 19-oct-2018.Expiration date: 2023-10-09.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.Considering the mat25763, no other similar event has been reported up today.Preliminary investigation performed by r&d project manager: the impactor head of the femoral impactor/extractor probably broke to excessive impacting force during final implant positioning or trying to completely position the final femur implant with this device.It is recommended to start the final implant positioning through this impactor and finish with monoblock impactor ref.77.11.0054.
Event or Problem Description
During a myknee efficiency case, whilst the surgeon was impacting the definitive femoral component, the efficiency femoral clamp broke into multiple pieces.A few small shards of plastic went into the wound and were retrieved by the surgeon, with about 2 minutes of delay.It is unknown if all pieces were retrieved, but the surgeon is pretty sure he got everything.The femoral cement impactor was used to finish implanting the femoral component.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: the visual inspection confirmed the hypothesis made during the preliminary investigation: the impactor head of the femoral impactor/extractor probably broke to excessive impacting force during final implant positioning or trying to completely position the final femur implant with this device.It is recommended to start the final implant positioning through this impactor and finish with monoblock impactor ref.77.11.0054.

• Brand Name: GMK SPHERE GENERAL SET
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8403058
• Report Number: 3005180920-2019-00137
• Device Sequence Number: 14035068
• Product Code: LXH
• UDI-Device Identifier: 07630030877414
• UDI-Public: 07630030877414
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2019

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: 10/09/2023
• Device Catalogue Number: 11.01001
• Device Lot Number: 188651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 04/04/2019
• 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
• Patient Age: 50 YR
• Patient Weight: 84