MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK TIBIAL IMPACTOR; SURGICAL INSTRUMENT FOR KNEE

Catalog Number	02.02.10.0001
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 29 apr 2019: lot 1411565: (b)(4) items manufactured and released on 06-oct-2014.No anomalies found related to the problem.To date, no similar event has ever been reported.Preliminary investigation from r&d (b)(4): from the analysis of the photos it is not clear the reason for the detachment of plastic pieces during final femoral impactions.We can imagine that the instruments was used against edges of metal instruments (tibial baseplate, cutting blocks) or that the instrument was used with excessive force (confirmed from the rounded and flattened corner of the blue impactor).
Event or Problem Description
During final impaction of the definitive femur, blue plastic splinters detached from the femoral impactor.The surgeon took about 10 minutes to remove them and check that they did not stay in the joint.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: the visual inspection confirmed what reported into the complaint form.We discovered a breakage of a little piece of blue plastic impactor.In addition, there are signs af damage on the external profile of the impactor probably due to a improper use or excessive force during impactions against instrument metal edges.The tibial impactor is one of the most critical instrument in terms of wear due to the different steps in witch it can be used during the surgery (piece produced in 2014).

• Brand Name: GMK TIBIAL IMPACTOR
• 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: 8564990
• Report Number: 3005180920-2019-00326
• Device Sequence Number: 19294044
• Product Code: LXH
• UDI-Device Identifier: 07630040764834
• UDI-Public: 07630040764834
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 07/23/2019

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 Catalogue Number: 02.02.10.0001
• Device Lot Number: 1411565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 07/23/2019
• 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: 65 YR