MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA TI 5.5 W/3 UB; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72202897

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 10/19/2020

Event Type  malfunction  

Event Description

It was reported that during a procedure when screwing the anchor, the twinfix broke from the stem, part of the handle, so the pins that holds it hooked off.The broken pieces were retrieved by suction and no additional bone holes were performed.The procedure was completed with a backup device and no delay or further complications reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history 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:- pathological conditions of bone, such a cystic changes or severe osteopenia, which would compromise secure anchor fixation - incomplete anchor insertion may result in poor anchor performance - use of 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.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: TWINFIX ULTRA TI 5.5 W/3 UB
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10814540
• MDR Text Key: 215465240
• Report Number: 1219602-2020-01811
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010652317
• UDI-Public: 03596010652317
• Combination Product (y/n): N
• PMA/PMN Number: K100159
• 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: 01/12/2021

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: 72202897
• Device Catalogue Number: 72202897
• Device Lot Number: 50883164
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention