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

Catalog Number	11.01002
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 06 jun 2019: general mis sphere instrument set ref 11.01002, lot 1901032: (b)(4) items manufactured and released on 01-mar-2019.Expiration date: 2024-02-18.No anomalies found related to the issue.To date, (b)(4) items of this lot have already been sold, without any other similar event registered.Considering the specific component femoral impactor/ extractor, ref77.11.0063, lot mat27910 ((b)(4) pieces): this is the 4th case received for the breakage of the central body.The other complaints are: (b)(4) [mdr2019-00448], (b)(4) and (b)(4).Preliminary investigation performed by r&d project manager: the breakage of a piece of the femoral impactor extractor head could have been caused due several factors such as an excessive tightening force applied during femoral implant fixation, excessive force/impactions trying to adjust the trial femoral positions (ml and flexum positioning).
Event or Problem Description
During the primary knee surgery and while impacting the femoral component, the gmk efficiency femoral impactor/extractor broke at the central part.No broken fragments fell into the patient's surgical wound and there was one minute delay in the case.The surgeon swapped to conventional instrumentation to complete the case and the surgery was completed successfully.

• Brand Name: GENERAL MIS SPHERE INSTRUMENT SET
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8691478
• Report Number: 3005180920-2019-00454
• Device Sequence Number: 1832081
• Product Code: LXH
• UDI-Device Identifier: 07630030882890
• UDI-Public: 07630030882890
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2019

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: 02/18/2024
• Device Catalogue Number: 11.01002
• Device Lot Number: 1901032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 06/12/2019
• 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