MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT L 56; SURGICAL INSTRUMENT FOR HIP

Catalog Number 01.26.10.0012

Device Problems Break (1069); Device Issue (2379)

Patient Problem No Information (3190)

Event Date 03/27/2018

Event Type  malfunction  

Event Description

During the case, a drill bit broke, and the hole that the drill bit goes through on the drill guide is very worn and misconfigured.The case was able to be completed with a second drill bit.There was no delay in surgery.The surgery was completed successfully.The broken drill bit is not available.The hospital disposed of it.

• Brand Name: MPACT FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT L 56
• Type of Device: SURGICAL INSTRUMENT FOR HIP
• 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, 6874 ; SZ 6874
• MDR Report Key: 7453592
• MDR Text Key: 106632085
• Report Number: 3005180920-2018-00262
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01.26.10.0012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other