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

Catalog Number 72202595

Device Problems Break (1069); Fracture (1260); Material Deformation (2976)

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

Event Date 10/11/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a shoulder cuff repair surgery, the twinfix ultra´s pk anchor broke.The device broke inside the patient, all the pieces were removed using tweezers.The s+n back up device was used in the same bone hole.There was a non significant surgical delay and no further complications were reported.

Manufacturer Narrative

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, suture strings and fractured anchor were returned.The anchor is fractured at the proximal end of the suture window.One of the prongs on the distal end of the insertion device is fractured away and the other is deformed.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 material specifications found that the raw material strength requirements and storage requirements are specified and each lot must be accompanied by a material certificate of analysis.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, 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: 18035574
• MDR Text Key: 326924998
• Report Number: 1219602-2023-02107
• 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: K152566
• 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: 12/27/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 72202595
• Device Lot Number: 2074108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2021
• 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 Sex: Female