MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMIS 01.15.10.0263 AMIS CUP IMPACTOR TERMINAL-M10; SURGICAL INSTRUMENT FOR HIP SURGERY

Catalog Number	01.15.10.0263
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 07 february 2019: lot 1851974: (b)(4) items manufactured and released on 02-aug-2018.No anomalies found related to the problem.To date, no other similar event has been reported on this lot.Additional component involved: cup: versafitcup cc trio 01.26.45.0046 acetabular shell cc trio ø 46 (k103352), lot 185442: 80.Items manufactured and released on 19-sep-2018.Expiration date: 2023-09-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Visual inspection performed by r&d project manager: during the visual inspection the terminal has been unscrewed from the cup using a production jaw with minimal torque.Analyzing the terminal it is visible that the balinit-c coating on the threaded part is scratched and also on the cup some scratches are present.It is possible that during the impaction the balinit-c coating has been detached and this caused the screw fixation on the cup.
Event or Problem Description
During the surgery the terminal for cup impaction remained blocked in the cup.The surgeon didn't have the 01.15.10.0293 screwdirver with t-handle to remove the terminal from the cup; he tried to release the adapter for about 10 minutes.Finally the surgeon used a back-up implant and instrument completing successfully the surgery.

• Brand Name: AMIS 01.15.10.0263 AMIS CUP IMPACTOR TERMINAL-M10
• 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: 8315264
• Report Number: 3005180920-2019-00032
• Device Sequence Number: 1650301
• Product Code: LXH
• UDI-Device Identifier: 07630040736015
• UDI-Public: 07630040736015
• 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): 02/07/2019

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: 01.15.10.0263
• Device Lot Number: 1851974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 02/07/2019
• 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