MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GENERAL SPHERE INSTRUMENT SET; SURGICAL INSTRUMENT FOR KNEE SURGERY

Catalog Number	11.01001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 17 june 2019: lot 1901001, code 11.01001: 20 items manufactured and released on 14 february 2019.Expiration date: 2024-02-13.No anomalies found related to the issue.To date, 10 items of the same lot have been already sold.Concerning the semi-finished device subject of this case: code 77.11.0063, lot mat27910: 1500 items manufactured and released on 20 december 2018.No anomalies found related to the issue, 4 similar cases received up to now.Preliminary investigation performed by medacta r&d project manager: the breakage of a piece of the femoral impactor extractor head could have been caused due several factors such as an excessive tightening force applied during femoral implant fixation, excessive force/impactions trying to adjust the trial femoral positions (ml and flexum positioning) : in any case we are investigate a new design of the impacting head in order to increase the radii of the external shape, increasing the surface in contact with the femoral component and increasing the resistance section of the device.The new design will be managed with mr 197-19.
Event or Problem Description
Femoral impactor extractor breakage (instrument central body) occurred while the surgeon was impacting the femur.There was no delay, and another instrument was used to complete the case.No pieces left in the patient.

• Brand Name: GENERAL SPHERE INSTRUMENT SET
• 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: 8707236
• Report Number: 3005180920-2019-00487
• Device Sequence Number: 19293992
• Product Code: LXH
• UDI-Device Identifier: 07630030877414
• UDI-Public: 07630030877414
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 06/18/2019

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: 02/13/2024
• Device Catalogue Number: 11.01001
• Device Lot Number: 1901001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/18/2019
• 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: 74 YR
• Patient Weight: 85