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

Model Number	72202897
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during an arthroscopy using a twinfix ultra, the inserter broke when entering the bone.The pieces were retrieved with tweezers.The original bone hole was expanded to use the backup.The procedure was completed with a 30 minutes or less delay using a back-up device.No further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional 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.There was a relationship found between the subject device and the reported incident.An analysis of the customer provided image revealed that at least three insertor tips had become detached from the devices, and one appeared to be loose.One of the detached tips appeared to be bent.Only one anchor was shown, and it did not appear to have any issues.No debris was shown.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 a repeat issue.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.A review of the insertor assembly found that the weld strength is specified and must be inspected for deformities, cracks, and gaps.The complaint was confirmed.Factors that could have contributed to the event include excess force or torque on the device or improper preparation of the insertion site.No containment or corrective actions are recommended at this time.

• Brand Name: TWINFIX ULTRA TI 5.5 W/3 UB
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11580063
• Report Number: 1219602-2021-00715
• Device Sequence Number: 11857700
• Product Code: MBI
• UDI-Device Identifier: 03596010652317
• UDI-Public: 03596010652317
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K100159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/22/2025
• Device Model Number: 72202897
• Device Catalogue Number: 72202897
• Device Lot Number: 2062903
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 03/27/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention