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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE PK, 11 X 25MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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SMITH & NEPHEW, INC. BIOSURE PK, 11 X 25MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Back to Search Results
Catalog Number 72202279
Device Problem Device Expiration Issue (1216)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/26/2018
Event Type  malfunction  
Event Description
It was reported that the expired device was implanted in the patient.
 
Manufacturer Narrative
Customer has filed an incorrect use of product.No further actions pursued at this time.If objective evidence, relevant information or product becomes available to assist with evaluation, the complaint will certainly be revisited.
 
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Brand Name
BIOSURE PK, 11 X 25MM
Type of Device
FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer Contact
jim gonzales
7000 west william cannon drive
austin, TX 78735
MDR Report Key7648464
MDR Text Key112786384
Report Number1219602-2018-00842
Device Sequence Number1
Product Code MBI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083635
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2018
Device Catalogue Number72202279
Device Lot Number50463306
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/27/2018
Date Device Manufactured06/03/2013
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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