MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA FEMORAL IMPACTOR/EXTRACTOR; 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	07/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 30 july 2019: lot 1902051: (b)(4) items manufactured and released on 20-mar-2019.Expiration date: 2024-03-06.No anomalies found related to the problem.To date, 14 items of the same lot have been already sold without any similar reported event.Concerning the semi-finished device subject of this case: code 77.11.0063, lot mat27910: (b)(4) items manufactured and released on 20 december 2018.No anomalies found related to the issue, 6 similar cases received up to now (this included).
Event or Problem Description
When the surgeon impacted the trial femoral component, both engaging parts of femoral impactor/extractor broke.

• Brand Name: FEMORAL IMPACTOR/EXTRACTOR
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8883097
• Report Number: 3005180920-2019-00684
• Device Sequence Number: 1642583
• Product Code: LXH
• UDI-Device Identifier: 07630030882890
• UDI-Public: 07630030882890
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/12/2019

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: 03/06/2024
• Device Catalogue Number: 11.01002
• Device Lot Number: 1902051
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 08/12/2019
• 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