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 Cut In Material (2454); Device Packaging Compromised (2916)

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

Event Date 10/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

During a labrum repair it was reported that when the package was opened, it was noticed that the suture of the anchor was cut.There was no damage on the package.Additional information received indicated that the surgeon found that the suture was cut when he pulled the sliding ring after inserting the anchor.Using a new site; a back-up device was used and the prepped site was left empty.The site was prepped with a drill.All pieces were removed from the patient so nothing was left inside the joint.There was no delay in the operation and no patient injury was reported.

Manufacturer Narrative

One suturefix ultra anr xl w/1 ultrabraid suture was returned for evaluation.Visual assessment confirmed the reported complaint of breakage.The suture has broken at the distal tip of the device, approximately mid-point of its length.The trigger has been advanced to the proximal end of the handle body indicating a complete deployment.The trigger was moved back to the pre-deployment position exposing the fork.One of the fork tines has been broken off.The additional fork tine is bent as well as the shaft.The condition of the broken and bent fork is consistent with excessive force being applied during use.Per the devices ifu 10601059 under precautions ¿use of excessive force during insertion can cause failure of the suture anchor or insertion device¿.No root cause related to the manufacturing process can be established.A review of the device history record was performed which confirmed no inconsistencies.After the evaluation, the root cause for the reported issue was determined to be user error.No further investigation is warranted at this time.(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: 5185024
• MDR Text Key: 30220724
• Report Number: 1219602-2015-01112
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2020
• Device Catalogue Number: 72203841
• Device Lot Number: 50542290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2015
• 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