MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA OFFSET-30° BROACH HANDLE - RIGHT; SURGICAL INSTRUMENT FOR HIP

Catalog Number	01.10.10.130
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 17 april 2019: lot 1311973b: (b)(4) items manufactured and released on 06-feb-2018.No anomalies found related to the problem.To date, no similar event has been reported on this lot.
Event or Problem Description
During surgery the instrument locking ball fell out of the handle.The ball did not fall in the patient.Straight broach handle used to complete the surgery.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: the spring ball plunger is came apart.It is possible this occurrence was influenced by variation in production/assembly however this cannot be confirmed.

• Brand Name: OFFSET-30° BROACH HANDLE - RIGHT
• Common Device Name: SURGICAL INSTRUMENT FOR HIP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8527547
• Report Number: 3005180920-2019-00298
• Device Sequence Number: 16603497
• Product Code: LXH
• UDI-Device Identifier: 07630040742115
• UDI-Public: 07630040742115
• 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): 05/22/2019

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: 01.10.10.130
• Device Lot Number: 1311973B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 05/22/2019
• 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