MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM 01.10.10.190 STEM REPOSITIONER; SURGICAL INSTRUMENT FOR HIP SURGERY

Catalog Number	01.10.10.190
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 11 february 2019: lot 1550208: (b)(4) items manufactured and released on 08-sep-2015.No anomalies found related to the problem.To date, another similar event has been reported on this lot.Preliminary investigation performed by r&d project manager: the images show the stem repositioner with the plastic jaw broken.The root cause of the event can not be determined with certainty, but it appears that the instrument was hit with the mallet that could have caused the damage on the repositioner.Concerning the impossibility of removal, the reason can be related to the stem well fixed in the femur.
Event or Problem Description
During the primary hip surgery and after all components were implanted, the surgeon was not able to reduce the patient.The surgeon attempted to extract the stem with the stem repositioner but the stem was well fixed and he was not able to explant the stem.During the process of attempting to extract the stem, the stem repositioner was struck with a mallet and it broke.After further examination, the surgeon determined that the reason he was not able to reduce the patient was that the stem was contacting the acetabulum.The surgeon then removed a small portion of bone from the acetabulum and the patient was easily reduced.There was a 40-minute delay in the case and the surgery was completed successfully.No fragments fell into the patient.Additional information: the instrument broke after being struck with mallet: the circled area is the broken part of the instrument.

• Brand Name: AMISTEM 01.10.10.190 STEM REPOSITIONER
• Common Device Name: SURGICAL INSTRUMENT FOR HIP SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8343137
• Report Number: 3005180920-2019-00058
• Device Sequence Number: 19353337
• Product Code: LXH
• UDI-Device Identifier: 07630040746809
• UDI-Public: 07630040746809
• 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): 02/15/2019

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: 01.10.10.190
• Device Lot Number: 1550208
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/15/2019
• 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