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

Model Number 72202971

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

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

Event Date 02/20/2018

Event Type  malfunction  

Event Description

It was reported that the surgeon was drilling the 4.5 drill bit out to the lateral cortex and upon coming back out, the tip of the drill bit broke off in the bone.It was retrieved without any issue.A backup device was available on hand for use.No patient injury was reported.

Manufacturer Narrative

Device was received for evaluation.Visual inspection confirmed that the drill bit is snapped just beyond the blade.The broken piece was returned.The cutting edges are in good condition.The lumen is laden with surgical matter.Cannulated surgical instruments such as drills and taps can become jammed due to soft tissue and bone fragment build up.The instrument¿s condition is consistent with this.Sudden starting and stopping of the drill bit in the bone may cause drill bit breakage.The coiled section returned is visibly bent.The coils have been permanently sprung and are no longer concentric.This area is sensitive to inadvertent torque force.The instrument is intended to flex but not bend.No root cause related to the manufacture of the device can be established.Use error may have been a contributing factor to the event.

• 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 ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7283976
• MDR Text Key: 100661644
• Report Number: 1219602-2018-00247
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010654526
• UDI-Public: (01)03596010654526(10)50652672
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202971
• Device Catalogue Number: 72202971
• Device Lot Number: 50652672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1