MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWNFX TI 2.8 HS STR ANCHR 2 DRBRD NDL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	7210301
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that during a wrist surgery, the twinfix anchor broke at the junction of anchor and suture during insertion.The procedure was completed with a s+n back-up device.It is unknown if there was a delay.No patient complications were reported.
Additional Manufacturer Narrative
H10: 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 no way to determine if the device contributed to the reported event.Insufficient product identification information was provided, and thus, a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.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 anchor specifications found that no burrs, cracks, or contamination are allowed.A certificate of conformance must be provided.Per complaint details, the anchor broke during insertion at the anchor/suture junction during a wrist surgery.Reportedly, the procedure was completed with a s+n back-up device.It is unknown if there was any surgical delay; however, no patient complications were reported.The patient impact beyond the reported device breakage and subsequent use of a backup device cannot be determined, although no patient injury/harm was reported.No further medical assessment can be rendered at this time.The complaint was not confirmed.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
H11: corrected data h6 (health effect - impact code).

• Brand Name: TWNFX TI 2.8 HS STR ANCHR 2 DRBRD NDL
• 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: 13865447
• Report Number: 1219602-2022-00419
• Device Sequence Number: 11941130
• Product Code: MBI
• UDI-Device Identifier: 03596010533845
• UDI-Public: 03596010533845
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K972326
• 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,Followup
• Report Date (Section B): 12/01/2022

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 Model Number: 7210301
• Device Catalogue Number: 7210301
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2022
• Supplement Date Received by Manufacturer: 06/29/2022; 12/01/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 06/30/2022; 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown