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

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	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 30 october 2018.Lot 185333: (b)(4) items manufactured and released on 13 july 2018.Expiration date: 2023-07-04.No anomalies found related to the semifinished component mat24506, (b)(4) pieces manufactured and 4 events on this lot.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Preliminary investigation performed by r&d project manager on the provided picture: the reason of breakage of the femoral impactor could be un excessive force applied through the handle during the instrument tightening.In this situation the two lateral harms could have been over stressed reducing resistance during impactions.Despite the femoral impactor/extractor is provide with a mechanical stop to avoid excessive force during tightening, the position of this stop is not optimized to completely eliminate the risk of breakage.
Event or Problem Description
During surgery the femoral impactor chipped while tightening the trial plastic femur.The surgeon used conventional instrumentation to complete the surgery.No fragments fell into the patient and no significant delay was reported.The instrument was thrown away.The surgery was completed successfully.

• Brand Name: GMK SPHERE GENERAL MIS SET
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8023974
• Report Number: 3005180920-2018-00839
• Device Sequence Number: 1464564
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2018

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: 07/04/2023
• Device Catalogue Number: 11.01002
• Device Lot Number: 185333
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/31/2018
• 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