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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 6MM X 25MM; SCREW, FIXATION, BONE

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SMITH & NEPHEW, INC. BIOSURE HA 6MM X 25MM; SCREW, FIXATION, BONE Back to Search Results
Model Number 72201769
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2023
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that during a surgery, the tip of the biosure ha screw broke and could not be screwed in.The procedure was completed with non-significant delay using a smith and nephew back up device.No further complications were reported.
 
Event Description
It was reported that during a surgery, the tip of the biosure ha screw broke and could not be screwed in.All the broken pieces were retrieved from the patient using tweezers.The procedure was completed with non-significant delay using a smith and nephew back up device.The back-up device was used in the originally drilled bone hole.Current status of the patient is good.No further complications were reported.
 
Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.A visual inspection revealed that it is not in its original packaging.The distal end of the screw is fractured away, there is debris on the device.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.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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the polymer specification found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.A clinical evaluation states that the provided undated/unlabeled photo was reviewed and appears to show the anchor screw broken at one end.However, the image does not provide insight into the root cause of the device breakage and that the ifu does caution that ¿excessive force should not be placed on the delivery instrument.The starter must be utilized with the screws to minimize screw breakage during insertion.¿ the root cause has been associated with unintended use of the device.Factors that could have contributed to the failure 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.
 
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Brand Name
BIOSURE HA 6MM X 25MM
Type of Device
SCREW, FIXATION, BONE
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 Key16452385
MDR Text Key310338889
Report Number1219602-2023-00282
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
PMA/PMN Number
K080358
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/05/2023
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 Number72201769
Device Catalogue Number72201769
Device Lot Number50909276
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/08/2023
Initial Date FDA Received02/28/2023
Supplement Dates Manufacturer Received03/09/2023
12/04/2023
Supplement Dates FDA Received03/13/2023
12/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/03/2020
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) Required Intervention; Other;
Patient Age29 YR
Patient SexFemale
Patient Weight48 KG
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