MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202626
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that during an arthroscopic rotator cuff repair procedure, the twinfix anchor tip broke while inserting into the bone.Backup device was available to complete the procedure.Non-significant delay and no patient complications were reported.
Additional Manufacturer Narrative
H10 h3, h6 part of the reported device was received for evaluation.There was no way to determine if the device contributed to the reported event.A complaint history review concluded this was a repeat issue.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was 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 risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the polymer found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.A visual inspection of the returned device found that it is not in its original packaging.The anchor and sutures were not returned with the device.There is debris on the shaft.No deficiencies can be seen on the device.Based on the condition of the product material found during visual inspection, additional material testing is not required.This case reports the breakage of the twinfix anchor, it is unknown if the broken anchor was retrieved from the patient.No clinically relevant supporting documentation was provided for inclusion in a medical investigation.The twinfix anchor is implantable, biocompatibility is not an issue.If retained micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.No further clinical/medical assessment is warranted at this time.The complaint was not confirmed, and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.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.

• Brand Name: TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12788632
• Report Number: 1219602-2021-02482
• Device Sequence Number: 4840302
• Product Code: MBI
• UDI-Device Identifier: 03596010647580
• UDI-Public: 03596010647580
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K151105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/15/2026
• Device Model Number: 72202626
• Device Catalogue Number: 72202626
• Device Lot Number: 50921915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2021
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male