MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMIS BROACH HANDLE; SURGICAL INSTRUMENT FOR HIP SURGERY

Catalog Number	01.15.10.0131
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
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 or wear of the instrument, however this cannot be confirmed.Evaluation of the solution on going.Batch review performed on (b)(6) 2019: lot 1754328: (b)(4) items manufactured and released on 12-mar-2018.No anomalies found related to the problem.To date another similar event has been reported on the same lot.Clinical evaluation performed by medical affairs director.A part of the broach handle got dismantled during impaction of the broach.The locking ball remained in the femoral canal, probably undetected by the surgeon until final xray, after stem implantation and surgical closure.The ball is made from surgical grade stainless steel, not meant for long term implantation, but the final position of the ball will probably shield it from mechanical stresses and from heavy vascularized areas, so it was probably decided that the removal would subject the patient to a much heavier risk than leaving it in the canal.There is no clinical cause for this event.We have no grounds to exclude that corrosion may take place, although we estimate this to be rather unlikely, based on anecdotic experience, and most probably the consequences of said corrosion would be minor.Sales representative reported as follows on (b)(6) 2019: the surgeon has informed the patient.There are no further steps.
Event or Problem Description
During surgery the spring and ball of the instrument fell into the patient's wound.The spring was found and removed while the ball remained in the patient.No revision surgery has been performed at the moment.

• Brand Name: AMIS BROACH HANDLE
• 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: 8711080
• Report Number: 3005180920-2019-00475
• Device Sequence Number: 16645272
• Product Code: LXH
• UDI-Device Identifier: 07630040768672
• UDI-Public: 07630040768672
• 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
• Report Date (Section B): 06/19/2019

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: 01.15.10.0131
• Device Lot Number: 1754328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/19/2019
• 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: 61 YR
• Patient Weight: 65