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

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	08/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 4 september 2019: lot 1211947c: (b)(4) items manufactured and released on 04-march-2019.No anomalies found related to the problem.Visual inspection performed by r&d 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.
Event or Problem Description
During surgery it was noticed that the spring of the lever arm of the broach handle was broken.The ball and the spring didn't fall into the patient.The surgeon switched without delay to the second handle that was in the set.

• Brand Name: HIP GENERAL OFFSET-30° BROACH HANDLE - RIGHT
• 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: 9115639
• Report Number: 3005180920-2019-00793
• Device Sequence Number: 16771530
• Product Code: LXH
• UDI-Device Identifier: 07630040742115
• UDI-Public: 07630040742115
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2019

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: 1311947C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/25/2019
• 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
• Patient Age: 70 YR
• Patient Weight: 70