MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AWL-DILATOR, TWINFIX ULTRA, 5.5MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72202634

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2014

Event Type  malfunction  

Manufacturer Narrative

One 5.5mm twinfix ultra dilator was returned for evaluation.Visual assessment of the device confirmed the reported complaint.The threaded portion of the distal tip has sheared off from the shaft.Examination of the break area shows no material voids.The proximal end of the handle is dented and flattened.Rockwell hardness testing verified the device shaft meets print specification.Device appears to have sustained a torsional overload during use causing the tip to shear from the shaft.Potentially the cause for this device failure was excessive forces were applied to the instrument, causing a result in failure.A review of the device history records and complaint files confirmed that no additional complaints have been reported and no abnormalities were noted during the manufacturing process for this lot.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 the tip broke off during use.Healthcare professional was able to retrieve the part with pliers.It was also reported that the entire distal end of the device broke off into the patient¿s bone.The procedure was able to be completed with a backup device, and the patient had no complications post-procedure.Healthcare professional stated that post-procedure there was no particular bone deficiency in the patient.No other complications were noted.

• Brand Name: AWL-DILATOR, TWINFIX ULTRA, 5.5MM
• 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: 5959077
• MDR Text Key: 55276290
• Report Number: 1219602-2016-00657
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2014

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: 72202634
• Device Lot Number: 50361029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2014
• Initial Date FDA Received: 09/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1