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	09/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 september 2019: lot 1551328: (b)(4) items manufactured and released on 18-july-2016.No anomalies found related to the problem.To date another similar event reported on this batch.Preliminary investigation 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
The instrument ball and spring mechanism popped out during surgery.No patient/user harm, the surgery was completed successfully.
Additional Manufacturer Narrative
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.Evaluation of the solution on going.The analysis was done on (b)(6) 2019.

• 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: 9178080
• Report Number: 3005180920-2019-00861
• Device Sequence Number: 3231909
• Product Code: LXH
• UDI-Device Identifier: 07630040742115
• UDI-Public: 07630040742115
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/11/2019

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: 1551328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 11/13/2019
• 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: 47 YR
• Patient Weight: 80