MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 2.8 DURABRAID; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72200762
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopy, the shaft of twinfix was found to be engraved with four laser marks, instead of two laser marks.It is unknown how the procedure was completed or if there was a delay.No patient complications were reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.It was determined the device contributed to 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.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 shaft drawing found that there are two axial laser marks 180° apart that correspond to the center of the opposite flats on the hex.A visual inspection of the returned device found that it is not in its original packaging.The device has been deployed, and the anchor and sutures were not returned.There is debris on the device.There are four laser vertical laser markings on the shaft of the device.Two markings on each side, approximately 180° apart.The markings are worn and scuffed.The complaint was confirmed, and the root cause was associated with manufacturing.A quality alert has been issued in response to this event.

• Brand Name: TWINFIX TI 2.8 DURABRAID
• 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: 13175718
• Report Number: 1219602-2022-00035
• Device Sequence Number: 4664921
• Product Code: MBI
• UDI-Device Identifier: 03596010584458
• UDI-Public: 03596010584458
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K972326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2026
• Device Model Number: 72200762
• Device Catalogue Number: 72200762
• Device Lot Number: 2067740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2021
• 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
• Patient Sex: Unknown