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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOINDUCTIVE IMPLANT W/ARTH DEL MED; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON

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SMITH & NEPHEW, INC. BIOINDUCTIVE IMPLANT W/ARTH DEL MED; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON Back to Search Results
Catalog Number 4565
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Fluid Discharge (2686)
Event Date 10/03/2023
Event Type  Injury  
Manufacturer Narrative
H10: internal complaint reference (b)(4).
 
Event Description
It was reported that after a right achilles tendon endoscopic debridement, excision of haglund¿s lesion and regeneten operation where a bioinductive implant was used, the patient had serious discharge over the wound, even after the wounds were healed and sto was done.A culture was taking from the wound and it was negative for any harmful pathogen.When the discharge was noticed, the patient was provided with oral augmentin, but the patient could not tolerate it and this let to vomiting.Therefore, the patient was administer 3 days of iv and 5 days of oral treatment.After 3 weeks the wound had dried up, and no further complications were reported.
 
Manufacturer Narrative
A device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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.The instructions for use were 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 clinical review states that based on insufficient information, a thorough clinical assessment cannot be performed at this time to determine the clinical root cause of the reported events.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.Corrected data: health effect - clinical and impact code.
 
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Brand Name
BIOINDUCTIVE IMPLANT W/ARTH DEL MED
Type of Device
MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer (Section G)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key18092723
MDR Text Key327635519
Report Number3003604053-2023-00071
Device Sequence Number1
Product Code OWY
UDI-Device Identifier00885556735657
UDI-Public885556735657
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K140300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/20/2023
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? No
Device Operator Health Professional
Device Catalogue Number4565
Device Lot Number2120655
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/18/2023
Initial Date FDA Received11/08/2023
Supplement Dates Manufacturer Received11/17/2023
Supplement Dates FDA Received11/20/2023
Date Device Manufactured05/24/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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