MAUDE Adverse Event Report: BIOMET, INC. 1.7 MM SCREW DRIVER

Model Number 231200101

Device Problems Break (1069); Component(s), broken (1103); Device remains implanted (1526)

Patient Problem Fracture, Arm (2351)

Event Date 01/06/2015

Event Type  malfunction  

Event Description

Dr was tightening a screw during right arm fixation, hexagonal screw and the tip broke off and got stuck in the screw head he was tightening.Tried to remove, but was unsuccessful.Per op report: upon screwing in the last screw, the most proximal screw became abnormal.This is being noted because it would make for a difficult hardware removal.If screw removal is done, first a biomet crosslock plate and second of all the plate may need to be fragmented to get the most proximal portion of the plate out along with that screw.

• Brand Name: 1.7 MM SCREW DRIVER
• Type of Device: SCREW DRIVER
• Manufacturer (Section D): BIOMET, INC.; 56 e bell dr; po box 587; warsaw IN 46581 058
• MDR Report Key: 4464411
• MDR Text Key: 5401244
• Report Number: 4464411
• Device Sequence Number: 1
• Product Code: HXX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 231200101
• Device Lot Number: CA59998
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/07/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2015
• Distributor Facility Aware Date: 01/06/2015
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 91