MAUDE Adverse Event Report: ARTHREX ARTHREX 3.5MM STEPPED DRILL

Device Problem Metal Shedding Debris (1804)

Patient Problem No Information (3190)

Event Date 01/12/2016

Event Type  malfunction  

Event Description

Surgeon utilizing an arthrex 3.5mm stepped drill sleeve during acl reconstruction surgery on right knee of (b)(6) year old female pt.Upon removal of the drill, the 'step' was noted to be missing and metal shards were visible at the site.Surgeon attempted to remove all pieces of metal.

• Brand Name: ARTHREX 3.5MM STEPPED DRILL
• Type of Device: ARTHREX 3.5MM STEPPED DRILL
• Manufacturer (Section D): ARTHREX; fort myers FL 99312
• MDR Report Key: 5608443
• MDR Text Key: 43768461
• Report Number: MW5061875
• Device Sequence Number: 1
• Product Code: HTW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18 YR