MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PK 4.5MM W/2 UB -WHT &BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72202595

Device Problems Crack (1135); Fracture (1260); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2023

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference case (b)(4).

Event Description

It was reported that, during a shoulder joint repair surgery, the tip of the screw of two (2) twinfix ultra cracked and twisted inside the patient, however, they did not fracture.The anchors were removed from the patient.Surgery was completed after a non-significant delay, using a back-up device in the originally drilled bone hole, no void was left on the patient.No further complications were reported.Patient's health status is good.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.A visual inspection of the returned devices found that they are not in their original packaging.Device 1: the insertion device, suture material and fractured anchor were returned with debris on all items.The distal end of the insertion device has the prongs slightly deformed.The anchor is fractured from the proximal end of the suture window in a spiral toward the proximal end of the anchor.Device 2: the insertion device, suture material and fractured anchor were returned with debris on all items.The distal end of the insertion device has one of the prongs fractured away and the remaining prong slightly bent.The anchor is fractured from the distal end, with the entire anchor split lengthwise to below the suture window.Based on the condition of the product material found during visual inspection, it was determined the device damage was caused by the application of improper/excessive force.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 specification 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 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, which could have contributed to the complaint event, include an application of unintended inappropriate or excessive force to 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 ULTRA PK 4.5MM W/2 UB -WHT &BL
• Type of Device: 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: 16801215
• MDR Text Key: 313897423
• Report Number: 1219602-2023-00593
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010647467
• UDI-Public: 03596010647467
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202595
• Device Catalogue Number: 72202595
• Device Lot Number: 2086829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 54 KG