MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 72202626

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

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

Event Date 09/04/2015

Event Type  malfunction  

Manufacturer Narrative

Visual assessment of the device confirmed the reported complaint of breakage.The anchor has broken at the suture eyelet and it appears to be missing several small pieces dimensional assessment of the anchor is prohibitive due to its condition.Removal of the anchor found the inserter intact.Dimensional assessment of the inserter confirmed it met print specifications.After the evaluation a definitive root cause for the reported issue could not be determined.A review of the device history records and complaint files confirmed that no additional complaints have been reported and no abnormalities were noted during the manufacturing process for this lot.There are no indications that would suggest that the device did not meet product specifications upon release into distribution.

Event Description

It was reported that during a rotator cuff repair procedure, the anchor broke upon insertion in the medical row.The piece broke in the patient and was removed.A backup device was use to complete the procedure.There were no reported patient injuries.No other complications were noted.

• Brand Name: TWINFIX ULTRA HA 5.5 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: 5974070
• MDR Text Key: 55886474
• Report Number: 1219602-2016-00962
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093844
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2019
• Device Catalogue Number: 72202626
• Device Lot Number: 50521221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1