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

Catalog Number	11.01001
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 21 march 2019: lot 1810892: (b)(4) items manufactured and released on 16-jan-2019.Expiration date: 2024-01-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Considering the (b)(4), no other similar event has ever been reported.Additional component that broke off during surgery: gmk sphere insert set i5l-t5 ref 11.01025 (lot 1812071): (b)(4) items manufactured and released on 16-jan-2019.Expiration date: 2023-12-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Considering the (b)(4), no other similar event has ever been reported.Preliminary investigation performed by r&d project manager: according to what reported by the surgeon, the cause of the impactor breakage was probably due to a very hard bone; in this situation, the surgeon probably needed to apply excessive force during impactions with also the risk of misalignment during the keel preparation.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.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 primary tka the tip of the impactor handle broke and it was impossible to get the trial keel out of the patient.After some attempts a metal chisel was used to get it out.Also in this case it was impossible to remove the trial keel, that broke off, too.They were forced to open a new gmk efficiency kit and use the new impactor handle successfully.The bone was very hard due to a tibia osteotomy carried out some years ago before the surgery.

• Brand Name: GENERAL SPHERE INSTRUMENT 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: 8443861
• Report Number: 3005180920-2019-00186
• Device Sequence Number: 14144652
• Product Code: LXH
• UDI-Device Identifier: 07630030877414
• UDI-Public: 07630030877414
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 03/22/2019

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: 01/01/2024
• Device Catalogue Number: 11.01001
• Device Lot Number: 1810892
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 03/22/2019
• 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: 62 YR