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

Catalog Number	11.01002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Preliminary investigation performed by r&d project manager: according to what reported into the complaint form, the impactor probably broke trying to remove the trial keel puncher; during this operation, the surgeon could have impacted / forced the handle laterally.The handle is intended to be impacted in its long axis.Improper impaction direction can overload the connection with a bending stress with the consequent risk of breakage of the handle-tip.The possibility to immediately use a new set in case of problem, is one of the key point of the efficiency instrumentation; the new device allowed to correctly remove the keel puncher and conclude the surgery with limited delay.In case of instrument breakage or even just in case of accidental fall of the instrument, the best solution is always to open a new set instead of trying to proceed with inappropriate tools as done during the surgery.
Event or Problem Description
During the primary knee surgery, and while the surgeon was using the impactor handle to extract the trial tibia and keel punch, the yellow piece on the handle broke.The surgeon used a new handle and there was a 5-minute delay in the case.The surgery was completed successfully.

• Brand Name: 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: 9030509
• Report Number: 3005180920-2019-00760
• Device Sequence Number: 3643043
• Product Code: LXH
• UDI-Device Identifier: 07630030882890
• UDI-Public: 07630030882890
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 09/13/2019

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: 11.01002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/13/2019
• 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