MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMIS STRAIGHT AMIS BROACH HANDLE; SURGICAL INSTRUMENT FOR HIP SURGERY

Catalog Number	01.15.10.0133
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 august 2019: lot 1859229: (b)(4) items manufactured and released on 27-jun-2019.No anomalies found related to the problem.To date, one other similar event has been reported.Preliminary investigation performed by r&d project manager: it is necessary to analyze the instrument.
Event or Problem Description
When the surgeon tried to remove the broach from the medullary cavity with the straight amis broach handle, the lever disengaged from the straight amis broach handle.Several parts disassembled and some were fell into the surgical field.All of them were able to retrieve.The surgeon removed the broach from the medullary cavity with another instrument.Due to this event, the surgery was prolonged about 10 minutes.
Additional Manufacturer Narrative
Visual inspection performed by medacta r&d hip project manager: there are signs of hammered close to lever pivot.The instrument was tested with a broach and it correctly works.It was tried to replicate the malfunction showed in the videos attached, this only occurs if the lever grip is moved away from the broach handle simulating the lever opening.That should not occur during femoral preparation because the surgeon hand wraps and block the lever grip.

• Brand Name: AMIS STRAIGHT AMIS BROACH HANDLE
• Common Device Name: SURGICAL INSTRUMENT FOR HIP SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8964687
• Report Number: 3005180920-2019-00743
• Device Sequence Number: 2883651
• Product Code: LXH
• UDI-Device Identifier: 07630040735254
• UDI-Public: 07630040735254
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/17/2019

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: 01.15.10.0133
• Device Lot Number: 1859229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 10/17/2019
• 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