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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PERFORMANCE SERIES SAGITTAL BLADE (13.0X1.27X90MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PERFORMANCE SERIES SAGITTAL BLADE (13.0X1.27X90MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL Back to Search Results
Model Number 6113127090
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/02/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The quality investigation is complete.
 
Event or Problem Description
It was reported that the blade broke at the teeth during a surgical procedure.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
 
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Brand Name
PERFORMANCE SERIES SAGITTAL BLADE (13.0X1.27X90MM)
Common Device Name
BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key12225032
Report Number3015967359-2021-01688
Device Sequence Number17237403
Product Code GFA
UDI-Device Identifier04546540501356
UDI-Public04546540501356
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/26/2021
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 Model Number6113127090
Device Catalogue Number6113127090
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/02/2021
Initial Report FDA Received Date07/26/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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