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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PRECISION THIN (9.0 X 0.38 X 31.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO PRECISION THIN (9.0 X 0.38 X 31.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL Back to Search Results
Catalog Number 2296003225
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device was not returned for investigation.The quality investigation is complete.Device discarded.
 
Event or Problem Description
It was reported that the blade broke at the mount during a foot/ankle procedure.It was further reported that there was a delay of a couple of minutes or less as a result to get a replacement blade.It was also reported there were no adverse consequences and the procedure was completed successfully.
 
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Brand Name
PRECISION THIN (9.0 X 0.38 X 31.0MM)
Common Device Name
BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8470426
Report Number0001811755-2019-01053
Device Sequence Number1651118
Product Code GFA
UDI-Device Identifier04546540046550
UDI-Public04546540046550
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/01/2019
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
Operator of Device Health Professional
Device Catalogue Number2296003225
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/05/2019
Initial Report FDA Received Date04/01/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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