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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTSTIRE_PRODUCT; DRILLS, BURRS, TREPHINES & ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTSTIRE_PRODUCT; DRILLS, BURRS, TREPHINES & ACCESSORIES Back to Search Results
Catalog Number UNK_ICO
Device Problem Fracture (1260)
Patient Problem No Patient Involvement (2645)
Event Date 07/06/2020
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
 
Event Description
It was reported that post operatively during disposal, the bur broke.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 post operatively during disposal, the bur broke.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 router involved with this event was returned for evaluation and the reported failure of breakage was confirmed.Further evaluation of the router was not possible as only a fragment of the router was returned.As only a fragment of the router was returned, the root cause of the router breaking is undetermined.
 
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Brand Name
UNKNOWN_INSTRUMENTSTIRE_PRODUCT
Type of Device
DRILLS, BURRS, TREPHINES & ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10329765
MDR Text Key200656631
Report Number0001811755-2020-01843
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_ICO
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2020
Date Manufacturer Received09/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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