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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PRECISION THIN (13.0 X 0.38 X 39.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO PRECISION THIN (13.0 X 0.38 X 39.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL Back to Search Results
Catalog Number 2296003108
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/19/2019
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting confirmation if device is available.
 
Event Description
It was reported that during a commando procedure (combined mandibulectomy and neck dissection operation), two blades broke.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.This report is for the second blade that broke.
 
Event Description
It was reported that during a commando procedure (combined mandibulectomy and neck dissection operation), two blades broke.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.This report is for the second blade that broke.
 
Manufacturer Narrative
H6: the device was not returned for investigation.The quality investigation is complete.H3 other text : device not returned.
 
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Brand Name
PRECISION THIN (13.0 X 0.38 X 39.0MM)
Type of Device
BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9474792
MDR Text Key170953918
Report Number0001811755-2019-04053
Device Sequence Number1
Product Code GFA
UDI-Device Identifier04546540046482
UDI-Public04546540046482
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/01/2022
Device Catalogue Number2296003108
Device Lot Number17345017
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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