MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL,FLEXIBLE,ENDOSCOPIC,CANN, 9MM; SAW, POWERED, AND ACCESSORIES

Catalog Number 7209738

Device Problem Break (1069)

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

Event Date 07/16/2014

Event Type  malfunction  

Manufacturer Narrative

Under magnification, minimal tip flaring was noted at one spot, the tip had rolled over on the inside of the body.The break is at the laser cut at the starting hole.The shaft of the device does not appear to have any other damage, other than the break.The countersink feature is reduced to an undersized condition.The root cause was determined to be over-sharpening of the tip.A review of the device history records was performed which confirmed no inconsistencies.A complaint history review has not identified additional complaints for this lot number on file.

Event Description

During an acl (anterior cruciate ligament) reconstruction surgery using a drill, flexible, endoscopic, cann, 9mm the flexible drill broke right below the head of the drill bit.All of the pieces were removed from patient.No patient injury or other complications were reported.

• Brand Name: DRILL,FLEXIBLE,ENDOSCOPIC,CANN, 9MM
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5975142
• MDR Text Key: 55794973
• Report Number: 1219602-2016-00996
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7209738
• Device Lot Number: 50370465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1