MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AWL-DILATOR, TWINFIX ULTRA, 4.5MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72202633

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2014

Event Type  malfunction  

Manufacturer Narrative

One twinfix ultra 4.5mm awl-dilator device was returned for evaluation of the reported complaint mode, ¿broken tip¿.The reported defect was confirmed.The awl dilator tip was broken at the start of the thread crest at the distal end of device; approximately.150¿ of device is missing.Visual damage was evident on the proximal tip of the handle; a ¿large depression¿ was found.The device appears to have been hit with excessive force, which may have caused the tip to fracture and break during use.Per the ifu (1060355) under precautions, ¿as with any surgical instrument careful attention should be exercised to ensure that excessive force is not placed on instrument.Excessive force can result in instrument failure.¿ the awl dilator shaft returned was verified to meet print dimensions, material specification, and required hardness.A review of the device history records was performed which confirmed no inconsistencies.There were no internal processing issues, which could have contributed to the nature of the complaint.A complaint history review has not identified additional complaints for this lot number on file.No further investigation is warranted at this time.(b)(4).

Event Description

During a rotator cuff repair it was reported that the doctor used the device for the second time and he could not get it to purchase.The surgeon had successfully used the awl for the first hole they were prepping for an anchor.The issue occurred while attempting to prep the second hole.The bone was very hard, and the surgeon may have twisted the awl to be at a different angle, while trying to get the awl to work.They were using a small mallet with the awl.The awl had been used previously in many cases.When the doctor put it on the back table, it was noticed the tip was broken off.It was recommended to take a metal anchor off of the shelf and use it in place of the tap device.The doctor pushed the piece of the awl dilator that broke further in, and kept the metal anchor in as well.The metal anchor was placed over the broken tip in the bone, and the procedure was completed successfully.There were no patient complications, and the patient was okay post-procedure.

• Brand Name: AWL-DILATOR, TWINFIX ULTRA, 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5318286
• MDR Text Key: 34785917
• Report Number: 1219602-2015-01263
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2014

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: Health Professional
• Device Catalogue Number: 72202633
• Device Lot Number: 50426398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/25/2014
• Initial Date FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1