MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT MULTIFUNCTION STRAIGHT HANDLE LONG; HIP INSTRUMENT

Catalog Number	01.26.10.0162
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During surgery, before the impacting of the liner, final impaction sphere ø32 detached from multifunction straight handle long and fell off in the surgical field.The surgery was completed successfully with the same instruments.When all devices were implanted, the nurse noticed that the multifunction straight handle long o-ring was missing and was found in the patient wound.While the surgeon was searching the o-ring damaged all implants, immediately replaced with new ones.The surgery was completed successfully.Delay time 3h on a total surgery time of 7h.Multifunction straight handle long was used only one time (during the present surgery).Final impaction sphere ø32 was not damaged.
Additional Manufacturer Narrative
Batch review performed on 02 august 2023.Lot 2251594: (b)(4) items manufactured and released on 21-march-2023.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot.
Additional Manufacturer Narrative
Piece returned on (b)(6) 2023.Visual inspection performed by r&d project manager: the issue was caused by the breaking of the o-ring.In fact the liner is kept in position by means of the grip exercised by o-ring.The root cause is unknown although it is likely the o-ring was damaged in a previous use of the instrument or during washing process.

• Brand Name: MPACT MULTIFUNCTION STRAIGHT HANDLE LONG
• Common Device Name: HIP INSTRUMENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17508569
• Report Number: 3005180920-2023-00646
• Device Sequence Number: 6363859
• Product Code: LXH
• UDI-Device Identifier: 07630040747448
• UDI-Public: 07630040747448
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2023

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: 01.26.10.0162
• Device Lot Number: 2251594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian