MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWNFX AB 5.0STR ANCR 2 38 ULTR THR DILTR; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 72200778

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 03/04/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the twinfix ab 5.0mm suture anchor broke off the insertion handle during implantation.Surgeon was using twinfix ab anchors to repair a rotator cuff tear in the shoulder.Surgeon prepared hole with dilator that comes with anchor, but upon insertion anchor snapped off inserter.Broken anchor was removed with a grasper.Surgeon used dilator to create another hole, and another anchor was used in its place.Delay was minimal - 2 mins.There was no report of patient injury associated with this event.

Manufacturer Narrative

Device investigation narrative - examination was not possible, as the device will not be returned.Without the return of the device in question a root cause for this incident cannot be determined.A review of the device history records and quality records associated with this manufactured lot confirmed that no additional complaints have been filed and that no abnormalities were reported with this product during manufacture.No further investigation is warranted at this time.(b)(4).

• Brand Name: TWNFX AB 5.0STR ANCR 2 38 ULTR THR DILTR
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, 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: 5497348
• MDR Text Key: 40540904
• Report Number: 1219602-2016-00135
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K011299
• 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: 03/07/2016

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 Expiration Date: 10/01/2017
• Device Catalogue Number: 72200778
• Device Lot Number: 50520194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2016
• Initial Date FDA Received: 03/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2014
• 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