MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX 2.8 TI W/NDL 22-0 ULTRABRAID; STAPLE, FIXATION, BONE

Model Number	72202067
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an unknown procedure, the twinfix anchor was introduced without problems, but when the sutures were passed through the tissues and the knots were tied, they broke without making a major effort.This happened with the two sutures, so the anchor could not be used.Surgery was resumed, after a non-significant surgical delay, with a back-up device.No further 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.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A review of the drawings found that that material certification of analysis is require for both sutures.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 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.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The twinfix suture anchor is implantable, biocompatibility is not an issue.If retained micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.No further clinical/medical assessment is warranted at this time.There was no relationship found between the device and the reported event.The complaint was not confirmed.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 2.8 TI W/NDL 22-0 ULTRABRAID
• Common Device Name: STAPLE, FIXATION, BONE
• 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: 15379706
• Report Number: 1219602-2022-01327
• Device Sequence Number: 5661539
• Product Code: JDR
• UDI-Device Identifier: 03596010619112
• UDI-Public: 03596010619112
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2022

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: 72202067
• Device Catalogue Number: 72202067
• Device Lot Number: 2082482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 11/08/2022
• Date Device Manufactured: 10/28/2021
• 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: Other
• Patient Age: 57 YR
• Patient Sex: Unknown
• Patient Weight: 62 KG