MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL, FLEXIBLE, ENDOSCPC, CANN, 4.5MM; ACCESSORIES, ARTHROSCOPIC

Catalog Number 72202971

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 07/29/2015

Event Type  malfunction  

Manufacturer Narrative

A visual inspection of the drill confirmed the reported breakage.The drill has broken in two places.All pieces were returned.The proximal end that interfaces with the drill chuck has been crushed and is discolored (burnt).The mid- section of the drill is broken at the laser cut section and is uncoiled.The distal end of the drill is also uncoiled at the break area.The cutting edges are dull and show wear.A dimensional assessment is unattainable due to the condition of the drill.Several conditions exist that likely contributed to the device failure; improper chucking, operating the drill in reverse and excessive forces being applied during use.There are no indications that would suggest the device did not meet product specifications upon release into distribution.

Event Description

During an acl reconstruction using the drill flexible endoscpc cann 4.5mm, the doctor was reaming the femoral tunnel when the device snapped into three pieces.It broke in the patient and was removed with graspers.A back up device was available for use.No patient injury or other complications were reported.

• Brand Name: DRILL, FLEXIBLE, ENDOSCPC, CANN, 4.5MM
• 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: 5971750
• MDR Text Key: 55679284
• Report Number: 1219602-2016-00901
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 72202971
• Device Lot Number: 50487934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/29/2015
• Initial Date FDA Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1