MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 72202624

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

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

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The distal end of the anchor has broken above the suture eyelet.The distal end of the anchor was not returned.Dimensional assessment of the anchors major diameter found it met print specifications.Examination of the inserter confirmed one inserter tine is missing and the other is bent and twisted.This condition is consistent with off axis insertion.No root cause related to the manufacture of the device can be established.There are no indications that would suggest the device did not meet product specifications upon release into distribution.

Event Description

It was reported on one anchor the metal tip broke off in the patient on insertion.The metal piece was retrieved.The second anchor it broke on insertion.No patient injury or other complications were reported.

• Brand Name: TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK
• 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: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5959978
• MDR Text Key: 55380893
• Report Number: 1219602-2016-00674
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• PMA/PMN Number: K093844
• 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
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/01/2020
• Device Catalogue Number: 72202624
• Device Lot Number: 50563935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1