MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 3.5 ULTRABRAID; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72200752

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Tissue Damage (2104)

Event Date 01/11/2019

Event Type  malfunction  

Event Description

It was reported that during the surgery the anchor cannot be screwed in completely.Back-up device was available to complete the surgery.Additional bone hole was required, loss of tissue was reported.

Event Description

It was reported that, during an unspecified surgery, the anchor could not be completely screwed in.A back-up device was available to complete the surgery; however, an additional bone hole was required.Loss of tissue fixation was reported.The patient was not stated to be injured.

Manufacturer Narrative

One twinfix ti 3.5mm suture anchor returned.The complaint stated: ¿the anchor cannot be screwed in completely.¿ the inserter, titanium anchor and ultrabraid suture were returned.There is damage noted from excess torque applied.The inserter shaft had been bowed and bent.The anchor displays signs of stripping began during attempt to seat anchor.Instructions for use for this device includes technique specific instructions.Use of a 2.5mm drill bit is the recommended prep instrument.Per instruction for use: ¿do not use sharp instruments to manage or control the suture.Excessive force during insertion can cause failure of the suture anchor or insertion device.A two-finger ao technique should be used to insert the anchor.Breakage of suture anchor can occur if predrilling is not performed prior to implantation.Either predrilling or use of a punch type device are recommended for site preparation, depending on the bone quality.It is the responsibility of the surgeon to determine the patient¿s bone condition, appropriately prepare the insertion site, and determine the suitability of the implant for the procedure.¿ no root cause associated with the manufacture of this device was confirmed.

• Brand Name: TWINFIX TI 3.5 ULTRABRAID
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8593028
• MDR Text Key: 144667536
• Report Number: 1219602-2019-00522
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010578921
• UDI-Public: 03596010578921
• Combination Product (y/n): N
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/27/2019

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: 03/17/2022
• Device Catalogue Number: 72200752
• Device Lot Number: 50653511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Manufacturer Received: 04/28/2019
• Initial Date FDA Received: 05/08/2019
• Supplement Dates Manufacturer Received: 05/24/2019
• Supplement Dates FDA Received: 05/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR