MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 2.8 ULTRABRAID; STAPLE, FIXATION, BONE

Catalog Number	72200750
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Perforation (2001); Device Embedded In Tissue or Plaque (3165)
Date of Event	12/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference:(b)(4).
Event or Problem Description
It was reported that during an acl, after a twinfix was implanted into the bone and the surgeon pulled the shaft out of the body, the suture of the twinfix came off.The anchor remained in the bone.Surgery resumed after a non-significant delay of 5 minutes with a back-up device used in an additional bone hole.No further complications were reported.No further details available.
Additional Manufacturer Narrative
The reported device was received for evaluation.A visual inspection revealed that it is not in its original packaging.The insertion device was returned with the ultrabraid suture string off the device.No anchor was returned.There is biological debris on the returned items.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 similar reported events.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.A review of the blueprints found that no burrs, cracks or contamination is allowed.Also a statement (c of c) or evidence of conformance to material and processing specifications must be provided.A clinical review states that based on the limited information provided, the definitive clinical root cause of the reported adverse event could not be determined.The implantable anchor was retained in the patient¿s bone, therefore, micro-motion and/or migration of the retained anchor is unlikely.The patient's impact was the retained anchor, the additional bone hole, and the 5-minute surgical delay.Since no other complications were reported, no further clinical/medical assessment is warranted at this time.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the failure 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.No containment or corrective actions are recommended at this time.

• Brand Name: TWINFIX TI 2.8 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: 18520241
• Report Number: 1219602-2024-00124
• Device Sequence Number: 20469358
• Product Code: JDR
• UDI-Device Identifier: 03596010584472
• UDI-Public: 03596010584472
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152566
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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 Catalogue Number: 72200750
• Device Lot Number: 2101773
• 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: 12/25/2023
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2022
• 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; Required Intervention
• Patient Sex: Unknown