MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T-FIX RCG STERILE PAC; SAW, POWERED, AND ACCESSORIES

Catalog Number 014771

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

When drilling into hard bone with the tfix drill attached to the chuck the tfix drill connection (chuck end) snapped off completely when drilling into the glenoid through the drill sleeve (hard bone).A backup device was readily available.There was a delay of less then 30 minutes.No patient injuries reported.

Manufacturer Narrative

Device investigation narrative - one 014771 t-fix rcg sterile pac (2mm sterile t fix rcg drill and sleeve) returned.The drill tail has been snapped off.Per a photo upon original receipt, it was returned but was inadvertently lost during internal transit.Upon final destination, that tail piece was absent from the package.There are scratches and dings on the blade flutes.The drill shaft and sleeve are bent at the distal end.There are gouges out of the sleeve tip.There are several spiral scratch bands along the sleeve shaft; proximal and distal.These are all signs losing axial alignment.Per the ifu: ¿as with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.¿ no root cause associated with the manufacture of this device could be supported nor proven.No further investigation warranted.

• Brand Name: T-FIX RCG STERILE PAC
• 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 ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 6639403
• MDR Text Key: 77710829
• Report Number: 1219602-2017-00602
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2021
• Device Catalogue Number: 014771
• Device Lot Number: 50606811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 20 YR