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

Model Number	72200750
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during shoulder rotator cuff repair, inside the patient, the suture of the twinfix ti 2.8 ultrabraid was broken.The procedure finished with a smith and nephew backup device.Surgical delay less than or equal to 30 minutes.Patient injuries were not reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: d9: updated, device received.H3,h6: the reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.An analysis of the customer provided image revealed that the inserter was standard, but the sutures were not shown.A visual inspection revealed that the device was not returned with the associated sutures.The anchor was returned with the device, and had some deformation on the threads causing sharp edges.The device shaft was coated in particulate debris, and had some markings at the proximal end.Based on the condition of the product material found during visual inspection no fracture of the implant could be confirmed.Additional material testing is not required.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 review of the suture material found that the storage specifications are documented and a material certificate is required with each lot.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.No containment or corrective actions are recommended at this time.

• Brand Name: TWINFIX TI 2.8 ULTRABRAID
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11690903
• Report Number: 1219602-2021-00898
• Device Sequence Number: 19810741
• Product Code: MBI
• UDI-Device Identifier: 03596010584472
• UDI-Public: 03596010584472
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K972326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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: 09/18/2024
• Device Model Number: 72200750
• Device Catalogue Number: 72200750
• Device Lot Number: 2040695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 05/19/2021
• 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