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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 5.0 ULTRABRAID; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

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SMITH & NEPHEW, INC. TWINFIX TI 5.0 ULTRABRAID; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Back to Search Results
Model Number 72200755
Device Problems Break (1069); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2022
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event Description
It was reported that during a shoulder cuff repair surgery, after implanted the twinfix suture anchor pulled out.The procedure was successfully completed using a back-up device in the original drilled bone hole, and a 4.5 starter was used to clear the insertion site.With no delay.No further complications were reported.Preliminary results of investigation found the anchor is fractured at the suture window and has biological debris on it.
 
Manufacturer Narrative
H10: 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 anchor was returned without the insertion device or suture material.The anchor is fractured at the suture window and has biological debris on it.A review of the customer provided image finds the anchor from the complaint device, fractured at the suture window.Based on the condition of the product material found during visual inspection, additional material testing is not required.A functional evaluation could not be performed due to the broken anchor.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 anchor specifications found that no burrs, cracks, or contamination is allowed.A certification of compliance to material and processing specifications is required.The root cause was associated with unintended use of the device.Factors that could have contributed to the break 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.Factors that could have contributed to the pull out include inadequate bone quality, improper preparation of the insertion site, or off-axis insertion of the device.No containment or corrective actions are recommended at this time.
 
Manufacturer Narrative
H10: 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 anchor was returned without the insertion device or suture material.The anchor is fractured at the suture window and has biological debris on it.A review of the customer provided image finds the anchor from the complaint device, fractured at the suture window.Based on the condition of the product material found during visual inspection, additional material testing is not required.A functional evaluation could not be performed due to the broken anchor.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 anchor specifications found that no burrs, cracks, or contamination is allowed.A certification of compliance to material and processing specifications is required.The root cause was associated with unintended use of the device.Factors that could have contributed to the break 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.Factors that could have contributed to the pull out include inadequate bone quality, improper preparation of the insertion site, or off-axis insertion of the device.No containment or corrective actions are recommended at this time.
 
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Brand Name
TWINFIX TI 5.0 ULTRABRAID
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 Key15746869
MDR Text Key303214298
Report Number1219602-2022-01690
Device Sequence Number1
Product Code MBI
UDI-Device Identifier03596010577986
UDI-Public03596010577986
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K972326
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 10/03/2023
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 Model Number72200755
Device Catalogue Number72200755
Device Lot Number2065597
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2022
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/17/2022
Initial Date FDA Received11/07/2022
Supplement Dates Manufacturer Received09/26/2023
09/26/2023
Supplement Dates FDA Received10/02/2023
10/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/15/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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