MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL, FLEXIBLE, ENDOSCOPIC, CANN, 10MM; SAW, POWERED, AND ACCESSORIES

Catalog Number 7209739

Device Problem Break (1069)

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

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

A visual inspection of the drill shaft shows it has broken proximal where it transitions to nine revs/inch.The break area exhibits no material voids.The cannulation at the drill head is deformed (flared); there is no measurable chamfer present.Dimensional and material specifications were inspected and confirmed to meet print specifications.This device likely broke due to over torquing during use.There are no indications that would suggest the device did not meet product specifications upon release into distribution.(b)(4).

Event Description

It was reported that the drill flexible endoscopic cann 10mm broke during the procedure.The piece was removed.No patient injury or other complications were reported.

• Brand Name: DRILL, FLEXIBLE, ENDOSCOPIC, CANN, 10MM
• 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: 5972851
• MDR Text Key: 55800106
• Report Number: 1219602-2016-00924
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/02/2015

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: Other
• Device Catalogue Number: 7209739
• Device Lot Number: 50536841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1