MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 5.0 ULTRABRAID; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72200755

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 07/23/2020

Event Type  Injury  

Event Description

It was reported that during a rotator cuff repair procedure, after the eployment of the anchor, when the insertor was disengaged from the anchor and pulled up, one of the suture also came out of the anchor.An additional bone hole was required and a backup device was available to complete the procedure.No delay and no patient complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

One 72200755 twinfix ti 5.0 ultrabraid device used in treatment, was not returned for evaluation.Evaluation was limited without product.If further information, the complaint may be revisited.Factors that might affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Influences that could compromise product performance or integrity include: 1) deviation from instructions for use recommendations.2) use of alternate site prep instruments.3) suture breakage due to alternate instrument use.4) dull drill bit used.5) unanticipated bone condition resulting in torsional overload.6) managing suture with sharp instruments.Per instructions 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.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.A 2.5mm drill bit is recommended for this product size.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¿.Complaint history review indicated no similar allegation for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Instructions for use contains recommendations and precautionary statements for proper use of product.Risk management files contain the reported failure.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.

Manufacturer Narrative

The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found that the device and suture were returned.The suture did not have any frays, cuts, or tears.There was some debris on the suture and inserter.The cause for the suture coming loose could not be determined.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.The complaint was confirmed, but the root cause could not be determined without the anchor present.Factors that could have contributed to the reported event include excessive force on the suture, securing only one side of the suture, or an assembly problem between the suture and anchor.Internal complaint reference: (b)(4).

• Brand Name: TWINFIX TI 5.0 ULTRABRAID
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10433478
• MDR Text Key: 203801044
• Report Number: 1219602-2020-01289
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010577986
• UDI-Public: 03596010577986
• 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,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200755
• Device Catalogue Number: 72200755
• Device Lot Number: 2043760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/20/2020
• Supplement Dates Manufacturer Received: 09/18/2020; 04/30/2021
• Supplement Dates FDA Received: 09/21/2020; 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR