MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA 4.5MM W/2 UB (BLK &BLUE); FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202894
Medical Device Problem Codes	Break (1069); Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an arthroscopy procedure using twinfix ultra suture anchor, by placing the anchor, it deployed from the shaft.It could not be used since the anchor had a broken piece.The procedure was successfully completed with non-significant delay using a back-up device.No other complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device 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 device and the reported event.A complaint history review found no similar reported events.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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the anchor found that no burrs, cracks, or contamination is allowed.A certification of compliance to material and processing specifications is required.A review of the customer provided image finds an insertion device with the distal tip fractured away.No anchor or suture material are shown.No relevant clinical information has been provided for inclusion in this medical investigation.Therefore, a thorough medical investigation cannot be rendered.One single undated, unlabeled photo was provided that supports the compliant.Based on the information provided, the procedure was successfully completed with a non-significant delay using a back-up device.Since no other complications were reported, no further clinical/medical assessment is warranted at this time.The complaint of break was confirmed and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.The complaint of premature activation was not confirmed.Factors that could have contributed to the reported event include unintended or excessive force to prematurely activate the device.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 investigation will be reopened for evaluation.

• Brand Name: TWINFIX ULTRA 4.5MM W/2 UB (BLK &BLUE)
• 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: 12764167
• Report Number: 1219602-2021-02435
• Device Sequence Number: 4151530
• Product Code: MBI
• UDI-Device Identifier: 03596010652256
• UDI-Public: 03596010652256
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K100159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2023

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: 04/16/2026
• Device Model Number: 72202894
• Device Catalogue Number: 72202894
• Device Lot Number: 2070532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 01/24/2023
• Date Device Manufactured: 04/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown