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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. TWINFIX ULTRA PK 4.5MM W/2 UB -WHT &BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Back to Search Results
Model Number 72202595
Device Problem Corroded (1131)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2021
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that during an arthroscopy, inside of the patient, there was rust between the nail body and metal rod of the twinfix.The procedure was successfully completed with 30 minutes of delay, after pulling it out, and fix it again with 5.5 external anchor.No other complications were reported.
 
Event Description
It was reported that during an arthroscopy, inside of the patient, there was rust between the nail body and metal rod of the twinfix.The procedure was successfully completed with a 30 minutes delay, after pulling the anchor out, and fix it again with a 5.5 external anchor.No other complications were reported.
 
Manufacturer Narrative
H2: additional information ¿b5, e1¿.
 
Manufacturer Narrative
Internal complaint reference (b)(4).H10 h3, h6: the reported device was received for evaluation.It was determined the device contributed to the reported event.A complaint history review concluded this was a repeat issue.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 part drawing found that a design change was implemented as part of a corrective action to preserve the quality of the device.The shaft is visually inspected for deformities, and a certificate of conformance for evidence of passivation is required.A review of the customer provided image found an arthroscopic view of the device in use.There is a brown discoloration on the laser marking of the device, but the substance cannot be identified in the image.A visual inspection of the returned device found that it is not in its original packaging.The anchor and sutures were not received with the device.There are no signs of corrosion on the device.There is biological debris on the shaft.The discoloration seen in the customer provided image cannot be seen on the device.The biocompatibility of the color variation material is unknown, and the possibility of localized pain/discomfort, cannot be ruled out if the material or residue from the reported ¿rust¿ remains in the patient.This is presumed to be unlikely with intraoperative surgical awareness and standard irrigation of arthroscopic procedures, but removal is not documented.No further medical assessment can be rendered at this time.The complaint was confirmed, and the root cause was associated with device design.A corrective action for this failure mode is in place.
 
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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 Key13108155
MDR Text Key282894635
Report Number1219602-2021-02792
Device Sequence Number1
Product Code MBI
UDI-Device Identifier03596010647467
UDI-Public03596010647467
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K093228
Number of Events Reported1
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 02/16/2022
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 Model Number72202595
Device Catalogue Number72202595
Device Lot Number2056329
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2022
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/01/2021
Initial Date FDA Received12/29/2021
Supplement Dates Manufacturer Received12/31/2022
02/15/2022
Supplement Dates FDA Received01/14/2022
02/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2021
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) Required Intervention;
Patient Age34 YR
Patient SexFemale
Patient Weight60 KG
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