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

Catalog Number 7209739

Device Problems Device Inoperable (1663); Device Dislodged or Dislocated (2923)

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

Event Date 08/16/2014

Event Type  malfunction  

Manufacturer Narrative

One 10mm endoscopic cannulated flexible drill was returned for evaluation.Visual assessment confirmed the reported breakage.The drill has broken where it transitions from the large to small laser cut double helix.No material voids are present at the break area.Rockwell testing confirmed the drill met print specification.The cutting edges are slightly dull but are in relatively good condition.There is no measurable countersink at the cannulation of the distal tip.The vendor has implemented a corrective action to ensure that the countersink is compliant.There are no indications that would suggest that the device did not meet product specifications upon release into distribution.

Event Description

It was reported that the device snapped during a procedure.Device was returned.It was indicated it must have been a defected drill bit because it had never been used and snapped when the healthcare professional first began to drill.Defect was noted because the tip stopped moving but the bottom half kept spinning during the procedure.The drill was used in forward and barely penetrated the bone.It was stated that the healthcare professional may have lost 5 minutes of time.Healthcare professional removed the flexible house pin and used a rigid one and drilled with a rigid reamer.No report of patient injury or surgical complication.No other complications were noted.

• Brand Name: DRILL, FLEXIBLE, ENDOSCOPIC, CANN, 10MM
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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: 5957009
• MDR Text Key: 55259915
• Report Number: 1219602-2016-00637
• Device Sequence Number: 1
• Product Code: NBH
• 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: 02/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7209739
• Device Lot Number: 50260235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1