MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE GENERAL MIS 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	08/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 21 august 2019: lot 1903049: (b)(4) items manufactured and released on 10-may-2019.Expiration date: 2024-04-28.No anomalies found related to the problem.To date, 5 items of the same lot have been already sold without any similar reported event.Concerning the semi-finished device subject of this case: code 77.11.0063, lot mat28583: (b)(4) items manufactured and released on 22 february 2019.No anomalies found related to the issue, no similar cases received up to now.
Event or Problem Description
When the surgeon impact the trial femoral component, both engaging parts of femoral impactor/extractor were broken.Broken device was discarded at the hospital.The surgery finished with the final impactor.No critical delay.

• Brand Name: GMK SPHERE GENERAL MIS 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: 8987627
• Report Number: 3005180920-2019-00761
• Device Sequence Number: 2923745
• Product Code: LXH
• UDI-Device Identifier: 07630030882890
• UDI-Public: 07630030882890
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 09/11/2019

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: 04/28/2024
• Device Catalogue Number: 11.01002
• Device Lot Number: 1903049
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/11/2019
• 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