MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TRIAL INSERT SIZE 3L - 8MM; SURGICAL INSTRUMENT FOR KNEE SURGERY

Catalog Number	02.18.10.0170
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 12 april 2019: lot 1652106: (b)(4) items manufactured and released on 04-nov-2016.No anomalies found related to the problem.To date, no similar event has been reported on this lot.Preliminary investigation performed by r&d project manager: the anterior part of the moto trial insert is broken at the pocket used to facilitate the trial insert removing from the trial baseplate.The breakage is not compatible with a normal use of the device; the instrument is provided with two rails that engage the slots of the tibia baseplate.The insertion/removal of the trial insert can be easily done by sliding the insert on the baseplate.The agent present during the surgery confirmed that the surgeon hit the insert during positioning instead of simply sliding it into the baseplate's grooves.We can imagine that the hit with metal mallet has damaged the insert and once the surgeons tried to remove it from the joint by using a kocher, the insert broke.
Event or Problem Description
During the primary knee surgery, the trial insert broke as it was being removed with a kocher clamp.The surgeon had hit it directly with a mallet to seat it into the tibial tray.No fragments fell into the patient's surgical wound and there was no delay in the case.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: the visual inspection confirms the root cause identified during the preliminary investigation reported in the initial report; the analysis of the pieces is compatible with the improper action reported by the agent.

• Brand Name: MOTO PARTIAL KNEE TRIAL INSERT SIZE 3L - 8MM
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8522858
• Report Number: 3005180920-2019-00277
• Device Sequence Number: 2516150
• Product Code: LXH
• UDI-Device Identifier: 07630971236608
• UDI-Public: 07630971236608
• 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,Followup
• Report Date (Section B): 05/23/2019

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: 02.18.10.0170
• Device Lot Number: 1652106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/23/2019
• 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