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

Catalog Number	01.10.10.131
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 7 august 2019.Lot 1211452c: (b)(4) items manufactured and released on 14-may-2018.No anomalies found related to the problem.To date, one other similar event has been reported on this lot.
Event or Problem Description
The ball and the spring of the lever from the offset broach handle was falling in the patient during the surgery.The part are removed from the patient.
Additional Manufacturer Narrative
Visual inspection performed by medacta r&d hip project manager: the spring ball plunger is came apart as described in the complaint.It is possible this occurrence was influenced by variation in production/assembly however this cannot be confirmed.Evaluation of the solution on going.

• Brand Name: HIP GENERAL OFFSET-30° BROACH HANDLE - LEFT
• Common Device Name: INSTRUMENT FOR HIP SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8949450
• Report Number: 3005180920-2019-00723
• Device Sequence Number: 2399797
• Product Code: LXH
• UDI-Device Identifier: 07630040742122
• UDI-Public: 07630040742122
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 01.10.10.131
• Device Lot Number: 1211452C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 10/04/2019
• 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