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	02/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 25 march 2019: general mis sphere instrument set 11.01002, lot 1810926: (b)(4) items manufactured and released on 22-jan-2019.Expiration date: 2024-01-09.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.Regarding the semifinished ref 77.11.0063 femoral impactor/ extractor (b)(4), no other similar event has been registered up today.Preliminary investigation performed by r&d project manager: the breakage of a piece of the femoral impactor extractor it is not compatible with the only attaching to the femoral component; the piece may have been damaged before (e.G.During trial femur positioning/impaction that could have generated a fracture on that area).Another factor that could have caused the breakage could be excessive tightening force applied during femoral implant fixation.
Event or Problem Description
During the primary tka and while attaching the femoral component to the femoral extractor to aide in cementing, a piece of the femoral extractor broke off.No fragments fell into the patient and the surgeon attached the femoral component to the femoral impactor in order to cement the implant.There was no delay in 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 8455412
• Report Number: 3005180920-2019-00189
• Device Sequence Number: 11467744
• 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): 03/27/2019

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: 01/09/2024
• Device Catalogue Number: 11.01002
• Device Lot Number: 1810926
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 03/27/2019
• 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