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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP UNKNOWN_INSTRUMENTSTIRE_PRODUCT; BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP UNKNOWN_INSTRUMENTSTIRE_PRODUCT; BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL Back to Search Results
Catalog Number UNK_ICO
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/08/2023
Event Type  malfunction  
Event Description
It was reported that during testing, three blades broke at the blade mount in the handpiece saw.It was also reported that this event did not occur during a surgical procedure, and there was no delay, medical intervention or adverse consequences as a result of this event.This report is for the third blade that broke.
 
Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.H3 other text : device discarded.
 
Manufacturer Narrative
H6: the quality investigation is complete.
 
Event Description
It was reported that during testing, three blades broke at the blade mount in the handpiece saw.It was also reported that this event did not occur during a surgical procedure, and there was no delay, medical intervention or adverse consequences as a result of this event.This report is for the third blade that broke.
 
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Brand Name
UNKNOWN_INSTRUMENTSTIRE_PRODUCT
Type of Device
BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
Manufacturer (Section G)
STRYKER INSTRUMENTS-IRELAND
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
EI   NA
Manufacturer Contact
una barry
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
EI   NA
214532900
MDR Report Key17037124
MDR Text Key316300143
Report Number3015967359-2023-01212
Device Sequence Number1
Product Code GFA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_ICO
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/16/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
4508000000 SN (B)(6)
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