MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWNFX TI 2.8 HS STR ANCHR 2 DRBRD NDL; STAPLE, FIXATION, BONE

Model Number	7210301
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during a distal reinsertion of the right biceps brachialis, a twinfix titanium anchor was being inserted but it broke in the patient's bone.It was not possible to remove the piece which had already been implanted in the patient's bone.A change of bone targeting order was performed.The procedure was completed without significant delay using a back-up device in an additional bone hole.No patient injury or other 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
Part of the device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection found that the screw was not returned with the device.The inserter and sutures were returned and no issues were found.The complaint was reviewed and found that no clinically relevant supporting documentation was provided for inclusion in this medical investigation.Since the retained anchor was left embedded in the bone, migration is unlikely.No further clinical/medical assessment is warranted at this time.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.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 review of risk management files found that the reported failure was documented appropriately.A review of the print specifications found that the storage requirements, material specifications, and applicable tests were appropriately specified.A material certificate of analysis was required for the raw material.The complaint was not confirmed and the root cause could not be determined as the condition in which the device was received did not allow for evaluation of the reported complaint.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: TWNFX TI 2.8 HS STR ANCHR 2 DRBRD NDL
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10875459
• Report Number: 1219602-2020-01900
• Device Sequence Number: 16867820
• Product Code: JDR
• UDI-Device Identifier: 03596010533845
• UDI-Public: 03596010533845
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K972326
• Number of Events Summarized: 1
• Summary Report (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): 08/12/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2025
• Device Model Number: 7210301
• Device Catalogue Number: 7210301
• Device Lot Number: 2050815
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 08/12/2021
• 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