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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO BONE VAC; TRAP, STERILE SPECIMEN
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STRYKER INSTRUMENTS-KALAMAZOO BONE VAC; TRAP, STERILE SPECIMEN Back to Search Results
Catalog Number 5400800000
Device Problem Particulates (1451)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2021
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device received but awaiting evaluation results.
 
Event Description
It was reported that there was a potential sterility breach on the packaging of the device, it was noted that there was foreign material in the pack during visual inspection prior to a surgical procedure.It was also reported that there was no adverse consequences and no delays as a result of this event and the procedure was completed successfully.
 
Manufacturer Narrative
H6: the quality investigation is complete.
 
Event Description
It was reported that there was a potential sterility breach on the packaging of the device, it was noted that there was foreign material in the pack during visual inspection prior to a surgical procedure.It was also reported that there was no adverse consequences and no delays as a result of this event and the procedure was completed successfully.
 
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Brand Name
BONE VAC
Type of Device
TRAP, STERILE SPECIMEN
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key11760885
MDR Text Key250863751
Report Number0001811755-2021-00764
Device Sequence Number1
Product Code BYZ
UDI-Device Identifier37613327502986
UDI-Public37613327502986
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 06/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5400800000
Device Lot Number20197B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2021
Initial Date Manufacturer Received 04/06/2021
Initial Date FDA Received05/03/2021
Supplement Dates Manufacturer Received05/28/2021
Supplement Dates FDA Received06/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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