MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GENERAL MIS SPHERE INSTRUMENT 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	02/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 18 march 2019: general mis sphere instrument set ref 11.01002, lot 187431: (b)(4) items manufactured and released on 12-sep-2018.Expiration date: 2023-09-24.To date, (b)(4) items of the same lot have been already sold without any similar reported event.No anomalies found related to the semifinished component mat25448, (b)(4) pieces manufactured; another similar event on this mat lot.Preliminary investigation performed by the r&d project manager: the breakage of the lateral impactor/extractor tooth may have been caused due to excessive tightening force during instrument assembling with trial femoral component.In this situation the resistant section is subjected to excessive forces with the risk of breakage during impactions (in this case for remove the trial from the bone).A second hypothesis of rupture could be that the instrument was used to completely impact the femoral trial component damaging the impactor extractor teeth; the subsequent use in extraction could have caused the final breakage of one of the teeth.
Event or Problem Description
During primary knee surgery and while attempting to remove the femoral trial, the efficiency femoral extractor broke and a fragment fell into the patient.A second efficiency femoral extractor was used to remove the femoral trial and the surgeon was able to recover the broken fragment that had fallen into the patient.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
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8436665
• Report Number: 3005180920-2019-00163
• Device Sequence Number: 3057555
• Product Code: LXH
• UDI-Device Identifier: 07630030882890
• UDI-Public: 07630030882890
• Combination Product (Y/N): N
• 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): 03/20/2019

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: 09/24/2023
• Device Catalogue Number: 11.01002
• Device Lot Number: 187431
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 03/20/2019
• 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