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

Catalog Number 72202633

Device Problems Break (1069); Difficult to Remove (1528); Device Or Device Fragments Location Unknown (2590); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/13/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

During a biceps tenodesis procedure it was reported that the device broke off inside the patient and could not be removed.A delay of one hour occurred as a result.The reported breakage occurred when the surgeon was prepping the hole for an anchor.He was on the final turn with the awl when the entire awl broke off into the biceptor groove.The doctor tried for an hour to remove the awl but was unable to.The awl was left in patient after calling and finding out the material composition of the device.The doctor finished the case by drilling and using a back-up anchor instead.

Manufacturer Narrative

Visual assessment of the device confirmed the reported breakage.The threaded distal tip has broken off at the transition of the threads to the.110 diameter of the shaft.The break area shows no material voids.Material condition was inspected and found to meet print specification.The proximal end of the handle is damaged, likely the result of impact from a mallet during use.This method of use is in conflict to the device ifu for both the anchor and awl-dilator.The healicoil ifu states ¿awl dilator: rotate the handle of the awl dilator clockwise until the laser mark is flush with the surface of the bone.To remove the awl dilator from the insertion site, rotate the device counterclockwise¿.Per the awl dilator ifu under precautions ¿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¿.After the evaluation, the root cause for the reported issue was determined to be user error.A review of the device history record was performed which confirmed no inconsistencies.

• 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: 5289046
• MDR Text Key: 33948753
• Report Number: 1219602-2015-01246
• 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,Followup
• Report Date: 11/13/2015

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: 50445682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2015
• Initial Date FDA Received: 12/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2013
• 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