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

Catalog Number 01.15.10.0263

Device Problem Failure to Disconnect (2541)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 09-august-2019 lot 1755175: (b)(4).No anomalies found related to the problem to date, no other similar events have been reported.Visual inspection performed by r&d project manager.During the analysis it is evaluated that the balinit-c coating of the terminal is removed from the area in connection with the cup, in addition some scratches are present of the whole body and finally the threaded part is damaged.Due to the damages indicated above the terminal was blocked in the cup as root cause.Additional device involved in the event, batch review performed on 09-august-2019 lot 1810201: (b)(4), expiration date: 2024-03-12.No anomalies found related to the problem to date, (b)(4) of the same lot have been already sold without any other similar reported event.

Event Description

After the surgeon impacted the cup, it was not possible to disconnect the terminal cup impactor.He had to explant the cup and use a new one with the straight cup impactor.There was a 5 minutes delay.

• Brand Name: AMIS CUP IMPACTOR TERMINAL-M10
• Type of Device: SURGICAL INSTRUMENT FOR HIP SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8969653
• MDR Text Key: 159368511
• Report Number: 3005180920-2019-00738
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07630040736015
• UDI-Public: 07630040736015
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/06/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 01.15.10.0263
• Device Lot Number: 1755175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 09/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other