MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M-VIZION PROXIMAL REAMER - ZIMMER HALL; INSTRUMENT FOR HIP SURGERY

Catalog Number	01.22.10.0156
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 21 august 2020: lot 1853895a: (b)(4) items manufactured and released on 09-jan-2020.No anomalies found related to the problem.To date, no other similar events have been reported.Additional device involved: m-vizion 01.22.10.0381 trial distal stem ø12mm l 140mm straight lot.1853964a.Batch review performed on 21 august 2020: lot 1853964a: (b)(4) items manufactured and released on 30-jan-2020.No anomalies found related to the problem.To date, no other similar events have been reported.Visual inspection performed by (b)(4) project manager: during the visual inspection was not identified any defect in the components, except the damages produced during the surgery that led to the proximal reamer ref 01.22.10.0156 breakage.The most likely root cause of the failure, in our opinion, is the application to the proximal reamer of a bending momentum during the reaming that resulted in an abnormal working condition and so to the failure of the component.The reaming is usually performed having the trial distal stem in the femur, the threaded rod fully screwed into the trial distal stem and the proximal reamer sliding on the threaded rod (used as guiding device) and spinning around the axis to ream the proximal femur.The axis of rotation of the proximal reamer should be coaxial to the stem axis.In this particular failed case, probably due to the anterior approach (possible interference of the instrument with the patience body) or to an excessive interference to the cortical bone (possible lack of proximal bone preparation with chisels or other instruments), the proximal reamer was forced to spin angled in respect to the stem with these effects: introduction of an unexpected bending momentum on the proximal reamer that led to the breakage of the weakest section (zimmer hall connector) the cutting blades of the proximal reamer damaged the surface of the trial distal stem connection cone.This kind of failure was never observed up to now (around 100 surgeries performed) and so no corrective action are suggested.Anyway, this failure will be added to a watch list and, if other similar failures will occur, a corrective action will be evaluated.
Event or Problem Description
During the revision hip surgery, as the surgeon was reaming over the distal stem for the proximal body, and as he was reaming the metal off the trial stem, the top of the reamer snapped off as he tried to get the reamer down.The surgeon had to use a high speed burr to completed the case.There was a 1-hour delay in the surgery and the surgery was completed successfully.Additional anesthesia was used on the patient and a loaner set was utilized.

• Brand Name: M-VIZION PROXIMAL REAMER - ZIMMER HALL
• Common Device Name: INSTRUMENT FOR HIP SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10501584
• Report Number: 3005180920-2020-00570
• Device Sequence Number: 304174
• Product Code: LXH
• UDI-Device Identifier: 07630040739276
• UDI-Public: 07630040739276
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2020

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: 01.22.10.0156
• Device Lot Number: 1853895A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 09/08/2020
• 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