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 Break (1069); Material Separation (1562)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2020

Event Type  Injury  

Event Description

It was reported that during a rotator cuff repair, the anchor broke while screw-in.The broken pieces were removed with tweezers.The procedure was successfully completed without significant delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that during a rotator cuff repair, the anchor broke while screw-in.The broken pieces were removed with tweezers.The procedure was successfully completed without significant delay using a back-up device in the originally drilled bone hole.No other complications were reported.Patient's current status is good.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H2: additional information ¿h6: health effect - clinical code and impact code, medical device problem code.¿ h3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the polymer, found that the storage requirements, material specifications, and applicable tests were appropriately specified.A material certificate of analysis was required for the raw material.A visual inspection of the returned device found that it is not in its original packaging.The insertion device, suture material and a fractured anchor were returned.All components have debris on them.Based on the condition of the product material found during visual inspection, additional material testing is not required.Per case details, the broken anchor was retrieved from the patient.The procedure was completed using a back-up device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.The complaint was confirmed, and the root cause was 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.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.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: 10667255
• MDR Text Key: 211247750
• Report Number: 1219602-2020-01565
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2024
• Device Model Number: 72202595
• Device Catalogue Number: 72202595
• Device Lot Number: 2034465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/12/2020
• Supplement Dates Manufacturer Received: 05/04/2022; 11/02/2022
• Supplement Dates FDA Received: 05/06/2022; 11/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Weight: 69 KG