MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA HIP GENERAL OFFSET-30 BROACH HANDLE - LEFT; SURGICAL INSTRUMENT FOR HIP SURGERY

Model Number	01.10.10.131
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 18 march 2021: lot 1111998: 11 items manufactured and released on 02-feb-2012.No anomalies found related to the problem.Since 2017 to date, no other similar events have been reported on this lot.Additional device involved: hip general 01.10.10.131 offset-30° broach handle - left lot.1111157.Batch review performed on 18 march 2021: lot 1111157: 15 items manufactured and released on 12-sept-2011.No anomalies found related to the problem.Since 2017 to date, no other similar events have been reported on this lot.Additional device involved: hip general 01.15.10.0133 straight amis broach handle lot.1952432 batch review performed on 18 march 2021: lot 1952432: 60 items manufactured and released on 03-sept-19.No anomalies found related to the problem.To date, another similar event has been reported on this lot.
Event or Problem Description
During the same surgery the broaches handles disassembled while the surgeon was switching from a broach to the next one.The surgery was completed successfully using extra straight broach handles, but there were 40 minutes of delay due to this issue.

• Brand Name: HIP GENERAL OFFSET-30 BROACH HANDLE - LEFT
• 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: 11626168
• Report Number: 3005180920-2021-00269
• Device Sequence Number: 14233363
• Product Code: LXH
• UDI-Device Identifier: 07630040742122
• UDI-Public: 07630040742122
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/07/2021

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 Model Number: 01.10.10.131
• Device Catalogue Number: 01.10.10.131
• Device Lot Number: 1111998
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 04/07/2021
• 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
• Patient Age: 55 YR
• Patient Weight: 95