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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 4.0MM ROUND FAST CUTTING BUR; BUR, DENTAL
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STRYKER INSTRUMENTS-KALAMAZOO 4.0MM ROUND FAST CUTTING BUR; BUR, DENTAL Back to Search Results
Catalog Number 1608006137
Device Problems Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 09/30/2019
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once 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 during visual inspection.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
 
Event Description
It was reported that there was a potential sterility breach on the packaging of the device, it was noted during visual inspection.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
 
Manufacturer Narrative
H6; the reported product involved with this event was returned for evaluation and the reported failure of packaging damaged/sterility compromised was confirmed.The device was sent to the packaging engineering team who concluded that it is likely that the damage to the packaging occurred during distribution (including handling) or storage of the product.The handling may have been more aggressive that expected or an unexpected event (such as a crush) occurred.A review of the product label indicates by way of an expandable label icon "do not use if package is damaged".
 
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Brand Name
4.0MM ROUND FAST CUTTING BUR
Type of Device
BUR, DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9258227
MDR Text Key164448642
Report Number0001811755-2019-03593
Device Sequence Number1
Product Code EJL
UDI-Device Identifier04546540030733
UDI-Public04546540030733
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1608006137
Device Lot Number19231017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2019
Date Manufacturer Received01/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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