MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM BROACH SIZE 2; SURGICAL INSTRUMENT FOR HIP SURGERY

Catalog Number	01.18.10.102
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received on (b)(6) reported by medacta (b)(4): we checked internally and confirmed there was no issue for coupling with the broach and the handle.Therefore, we do not ship the devices for the investigation.Batch review performed on (b)(6) 2019: lot 1111219: (b)(4) items manufactured and released on 22-nov-2011.No anomalies found related to the problem.To date, no similar event has been reported on this lot (both considering bone fracture and failure of coupling).Additional instrument involved in the event (failure of coupling): batch review performed on (b)(6) 2019: amis 01.15.10.0131 amis broach handle, lot 1653995: (b)(4) items manufactured and released on (b)(6) 2017.No anomalies found related to the issue.To date, another similar event has been registered on this lot.
Event or Problem Description
During surgery the femoral bone broke when the surgeon tried to engage the handle with the rasp.Femoral bone was fixed with the wire.The surgeon commented that it was hard to engage the handle with the rasp.

• Brand Name: AMISTEM BROACH SIZE 2
• 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: 8486483
• Report Number: 3005180920-2019-00247
• Device Sequence Number: 14082322
• Product Code: LXH
• UDI-Device Identifier: 07630040751780
• UDI-Public: 07630040751780
• 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
• Report Date (Section B): 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 01.18.10.102
• Device Lot Number: 1111219
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 04/05/2019
• 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: Required Intervention
• Patient Age: 73 YR