MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWNFX TI 6.5 PRLD ULTRBRD; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 7210709

Device Problems Break (1069); Sticking (1597)

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

Event Date 04/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the anchor handle broke when the anchor was being inserted during a proximal hamstring re-attachment.Surgeon pre-drilled with a 2.9 mm ao drill.The anchor was stuck half in, half out.The surgeon had to remove the anchor using pliers.Another twinfix handle broke trying to remove it.Overall this caused a 20 minute delay to the case.Another twinfix ti ultra 6.5 was used to complete the case.There was no associated patient injury reported.

Manufacturer Narrative

Device investigation narrative - device is not being returned for evaluation.The clinical details provided were reviewed, and it was identified that the insertion site was prepared using a 2.9 mm ao drill.Per the device ifu ¿the 3.5mm drill bit size is recommended for the 6.5mm anchor.Excessive force during insertion can cause failure of the suture anchor or insertion device.¿ it was further reported that there was no reported patient impact as a result of the device failure, and nothing was left unsupported in the patient.No further clinical assessment is warranted at this time.Further investigation is not warranted at this time.(b)(4).

• Brand Name: TWNFX TI 6.5 PRLD ULTRBRD
• 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: 5599774
• MDR Text Key: 44197511
• Report Number: 1219602-2016-00200
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K053344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Catalogue Number: 7210709
• Device Lot Number: 50475427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2013
• 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