MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX ULTRA AHR XL, #2 UB BLUE/WH; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72203842

Device Problems Cut In Material (2454); Device Operates Differently Than Expected (2913)

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

Event Date 08/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the anchor was implanted and when they went to remove the inserter, it cut the stitch.A backup anchor was used in another hole to complete the procedure.A short delay of less than 30 minutes was reported.There was no report of patient impact associated with this event.

Manufacturer Narrative

Visual assessment found one end is heavily frayed.The distal tip of the outer tube has been pinched off and rolled over.Additionally the outer tube is bowed.The nose tube subassembly was removed from the handle to inspect for additional damage, the fork was exposed and the tines (2) have been broken off and were not returned for examination.The fork is bent at the break area.The condition of the break area indicates that an excessive amount of torque was placed on the inserter during use.A review of the device history records and quality records associated with this manufactured lot confirmed that no additional complaints of this nature have been confirmed and that no abnormalities were reported with this product during manufacture.

• Brand Name: SUTUREFIX ULTRA AHR XL, #2 UB BLUE/WH
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5950803
• MDR Text Key: 55047521
• Report Number: 1219602-2016-00613
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2020
• Device Catalogue Number: 72203842
• Device Lot Number: 50577509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2015
• 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