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

Catalog Number	01.10.10.131
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 25 february 2019: lot 1111995c: (b)(4) items manufactured and released on 10-apr-2018.No anomalies found related to the problem.To date, no other similar event has been reported on this lot.
Event or Problem Description
During the impaction the ball of the broach handle fell out from the passing hole and the spring was broken, no debris fell in the patient.There was a delay of max.Five minutes.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: the spring ball plunger come apart.It is possible that this occurrence could have been influenced by instrument wear or variation in production/assembly, however this cannot be confirmed.

• 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 8377334
• Report Number: 3005180920-2019-00097
• Device Sequence Number: 2326999
• Product Code: LHX
• 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): 03/26/2019

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: 01.10.10.131
• Device Lot Number: 1111995C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 03/26/2019
• 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