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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 4.2MM RADIOLUCENT DRILL BIT; BIT, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO 4.2MM RADIOLUCENT DRILL BIT; BIT, SURGICAL Back to Search Results
Model Number 4200355042
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/28/2020
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 during a t2 tibia surgery, two radiolucent drill bits broke.It was further reported that one of the drill bits was reused.It was also reported that there were no delays and no adverse consequences as a result of this event and the procedure was completed successfully.This record addresses one of the drill bit breaking.
 
Manufacturer Narrative
H6; the reported product involved with this event was returned for evaluation and the reported failure of drill bit breakage was confirmed.The drill bit was evaluated by product engineering who concluded that the heads of both the bits were not returned for analyses, meaning they could not be assessed for evidence that could indicate how the fracture occurred.The slight bends in both the bits, as well as the clean and homogeneous fracture surfaces, would suggest that an excessive bending force caused the fractures.The instruction for use(ifu) for the handpiece for use with this drill bit contain the following caution under the warning section "excessive pressure can damage either the drill bit or driver.".
 
Event Description
It was reported that during a t2 tibia surgery, two radiolucent drill bits broke.It was further reported that one of the drill bits was reused.It was also reported that there were no delays and no adverse consequences as a result of this event and the procedure was completed successfully.This record addresses one of the drill bit breaking.This record addresses the drill bit that was not re-used.
 
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Brand Name
4.2MM RADIOLUCENT DRILL BIT
Type of Device
BIT, SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9876515
MDR Text Key186735248
Report Number0001811755-2020-00786
Device Sequence Number1
Product Code GFG
UDI-Device Identifier04546540348593
UDI-Public04546540348593
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 05/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/01/2022
Device Model Number4200355042
Device Catalogue Number4200355042
Device Lot Number19288017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2020
Date Manufacturer Received05/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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