MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWIST DRILL,FLEX,CRVD, FOR 2.3 SA; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72203160

Device Problems Break (1069); Detachment Of Device Component (1104); Sticking (1597)

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

Event Date 05/20/2015

Event Type  malfunction  

Manufacturer Narrative

Visual inspection confirmed that the drill head has broken free from the flexible coil.The breakage of the device has occurred at the distal weld zone of the flexible coil to the drill head.Drill head was not returned for examination.Examination of the break area shows adequate weld penetration.This location is the high stress zone of the drill.The breakage is consistent with excessive torsional force being applied during use.Potentially the cause for this device failure was excessive forces applied to the instrument, causing a result in failure.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 while drilling the fourth and last hole, the distal tip of the drill broke off from the main part of the drill and became stuck in the bone.Healthcare professional was able to remove the tip with an arthroscopic grasper.The procedure was completed successfully.There were no reported patient injuries.No other complications were noted.

• Brand Name: TWIST DRILL,FLEX,CRVD, FOR 2.3 SA
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 5966969
• MDR Text Key: 55622902
• Report Number: 1219602-2016-00797
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K102660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2020
• Device Catalogue Number: 72203160
• Device Lot Number: 50533339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15
• Patient Weight: 90