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	03/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 12 april 2019: gmk sphere general mis set 11.01002, lot 1812011: (b)(4) items manufactured and released on 30-jan-2019.Expiration date: 2024-01-16.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.Considering the pin extractor specific (b)(4) no other similar case has been reported before.Preliminary investigation performed by r&d (b)(4): from the image of the claim it is not possible to identify the real cause of the event.As described we can imagine that the surgeon applied excessive force trying to remove the pin from a very hard bone.In any case we tried to simulate the same breakage occurred during the surgery applying big lateral force but we were not able to break the device.This is the first case and, in the absence of a clear reason for failure, we will continue to monitor the market.
Event or Problem Description
Gmk efficiency pin puller broke at hinge point during operation.Surgery completed successfully and without delay using the metal pin puller.No part fell into the patient.

• 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: 8514350
• Report Number: 3005180920-2019-00274
• Device Sequence Number: 11233687
• Product Code: LXH
• UDI-Device Identifier: 07630030882890
• UDI-Public: 07630030882890
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/15/2019

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: 01/16/2024
• Device Catalogue Number: 11.01002
• Device Lot Number: 1812011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2019
• Initial Report FDA Received Date: 04/15/2019
• 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
• Patient Age: 72 YR