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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 18.5MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO PRECISION THIN (9.0 X 0.38 X 18.5MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL Back to Search Results
Model Number 2296003255
Device Problem Fracture (1260)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2020
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
 
Event Description
It was reported via medwatch 5095700, that during an acl (anterior cruciate ligament) procedure, the blade broke at the mount.It was also reported that there was a seven minute delay as a result of this event.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.
 
Manufacturer Narrative
H6: the quality investigation is complete.
 
Event Description
It was reported via medwatch 5095700, that during an acl (anterior cruciate ligament) procedure, the blade broke at the mount.It was also reported that there was a seven minute delay as a result of this event.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.
 
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Brand Name
PRECISION THIN (9.0 X 0.38 X 18.5MM)
Type of Device
BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10520954
MDR Text Key207297524
Report Number0001811755-2020-02368
Device Sequence Number1
Product Code GFA
UDI-Device Identifier04546540466617
UDI-Public04546540466617
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 10/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2296003255
Device Catalogue Number2296003255
Device Lot Number19340017
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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