MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PK 5.5MM W/2 UB-WHT & BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202599
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the shoulder cuff repair surgery, the front end of the twinfix ultra anchor was fractured while the implantation.The procedure was completed using a back-up device.The back-up device was used in the originally drilled bone hole, there was no void left in the patient and the site was cleared prior to the insertion of the anchor.There was less than 30 minute surgical delay.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H2: additional information on: b5.H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The insertion device was returned with the anchor fractured at the suture window and held in place with both suture strings.There is biological debris on the returned items.Based on the condition of the product material found during visual inspection, additional material testing is not required.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.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 anchor material specifications found that tensile strength requirements are specified.A material certificate of analysis (coa) is required for raw material.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, off-axis insertion, or an inadvertent impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
Event or Problem Description
It was reported that during the shoulder cuff repair surgery, during implantation, the front end of the twinfix ultra anchor cracked but no pieces were detached.The procedure was completed using a back-up device.The back-up device was used in the originally drilled bone hole, there was no void left in the patient and the site was cleared prior to the insertion of the anchor.There was less than 30 minute surgical delay.No further complications were reported.

• Brand Name: TWINFIX ULTRA PK 5.5MM W/2 UB-WHT & BL
• 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: 18732281
• Report Number: 1219602-2024-00307
• Device Sequence Number: 6349490
• Product Code: MBI
• UDI-Device Identifier: 03596010647474
• UDI-Public: 03596010647474
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2024

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 Catalogue Number: 72202599
• Device Lot Number: 2089442
• 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: 01/29/2024
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 70 KG