MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TF ULTRA 2 UBRAID AND NDLS 5.5MM TI; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202618
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during rotator cuff tendon repair, the anchor came out from bone hole when tying the sutures.The procedure was completed using loose sutures with needles.It is unknown if a delay occurred.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.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.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Event or Problem Description
It was reported that during rotator cuff tendon repair, the anchor came out from bone hole when tying the sutures, the anchor was removed.The procedure was completed with needle sutures, fixing the tendon to the bone.No additional bone holes were required.20 minutes of delay occurred.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: TF ULTRA 2 UBRAID AND NDLS 5.5MM TI
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11676129
• Report Number: 1219602-2021-00874
• Device Sequence Number: 3015546
• Product Code: MBI
• UDI-Device Identifier: 03596010656131
• UDI-Public: 03596010656131
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2021

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: 08/20/2023
• Device Model Number: 72202618
• Device Catalogue Number: 72202618
• Device Lot Number: 50753807
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 04/20/2021; 05/12/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 04/21/2021; 05/13/2021
• 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: Required Intervention