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 Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the surgeon was doing a labral repair in the hip.While inserting first anchor, once inserted and removing the inserter the anchor came out with the inserter and a piece of metal was seen in the joint.This metal was removed safely with no damage to the patient and an approximate 5 min delay to the case.The piece was removed with a grasper.Case was completed with competitor product.No response received for any impact to the patient.

Manufacturer Narrative

Device investigation narrative - one suturefix ultra anr xl was returned for evaluation.Visual assessment confirmed the reported complaint of breakage.The distal end of the inner shaft has broken off.The broken portion is bent in two places and is twisted.The anchor /suture construct was not returned for evaluation.The inserter shaft distal tip is slightly bent.The condition of the device indicates that an excessive amount of force was placed on the inserter during anchor insertion.The suture cover has been broken off of the handle.The condition of the device indicates that excessive forces were applied to the device during anchor insertion.Per the device ifu 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.Further investigation is not 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5605754
• MDR Text Key: 44350705
• Report Number: 1219602-2016-00202
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K122059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2019
• Device Catalogue Number: 72203841
• Device Lot Number: 50525668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2014
• 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