MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMIS TERMINAL CUP IMPACTOR FOR METAL BACK CC; SURGICAL INSTRUMENT FOR HIP SURGERY

Catalog Number	01.15.10.0261
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 27 february 2019: lot 1411056: (b)(4) items manufactured and released on 04-sep-2014.No anomalies found related to the problem.To date, this is the 8th similar reported event on this lot (complaints (b)(4) [mdr2014-00160], (b)(4) [mdr 2015-00025], (b)(4) [mdr 2015-00139], (b)(4) [mdr 2015-00307], (b)(4) [mdr 2015-00345], (b)(4) [mdr 2017-00415], (b)(4) [mdr 2017-00583]).Visual inspection performed by r&d project manager: the terminal was blocked inside the cup.Using a depicted screwdriver 01.15.10.0293 we have implanted the cup in a sawbones block pcf30 after reaming with 48mm diameter.Then the screwdriver has been used to easily unscrew the terminal from the cup with success.Looking at the terminal it is evaluable that there are some scratches on the balinit-c and in addition some scratches are present on the cup surface: also the threaded part is a little bit scratched.These scratches are the possible root cause of the terminal block inside the cup.
Event or Problem Description
The surgeon was not able to disconnect the terminal for cup impactor from the cup.The surgery was completed successfully using back-up implant and instrument.

• Brand Name: AMIS TERMINAL CUP IMPACTOR FOR METAL BACK CC
• 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: 8381776
• Report Number: 3005180920-2019-00107
• Device Sequence Number: 240451
• Product Code: LXH
• UDI-Device Identifier: 07630040735995
• UDI-Public: 07630040735995
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 03/01/2019

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: 01.15.10.0261
• Device Lot Number: 1411056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 03/01/2019
• 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