MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX UL ANR XL W/1 #2 ULTRABRIAD BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72203841

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

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

Event Date 08/26/2014

Event Type  Injury  

Event Description

During a hip arthroscopy using the suturefix ul anr xl w/1 #2 ultrabraid bl it was reported that one of the forks tines on the inserter broke.The all suture anchor was removed and a 2.3 was implanted in its place.The location of the broken tine is unknown.The surgeon took c-arm images to ensure the tine was not in the patient.Also, the surgeon took arthroscopic images of the 1.7 drill hole after the all suture anchor was removed to conform the tine was not in the drill hole.A backup device was available to complete the procedure.There was no reported procedural delay.The patient¿s post-operative condition was status quo.The site was prepped with standard 1.7 suturefix technique.The suture anchor had not been rotated after insertion.

Manufacturer Narrative

It was reported that one of the nitinol fork tines on the inserter of the suturefix ultra suture anchor xl broke off.The returned device was visually inspected, and the fork was confirmed to be broken.In addition to visual inspection, the part was inspected for tine thickness and width, and the material was analyzed.The dimensions were found to be within specification, and the material was confirmed to be nitinol.Further failure analysis was conducted by ((b)(4)) using scanning electron microscopy (sem).Through their analysis, it was determined that the sample ¿failed from overload¿, and that there ¿were no indications of faulty raw material, poor workmanship, or preexisting damage¿.Per ifu 10601059: ¿use of excessive force during insertion can cause failure of the suture anchor or insertion device (b)(4).

• Brand Name: SUTUREFIX UL ANR XL W/1 #2 ULTRABRIAD BL
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 4960282
• MDR Text Key: 18640764
• Report Number: 1219602-2015-00652
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 72203841
• Device Lot Number: 50482867
• Other Device ID Number: 200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 19 YR