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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP RECIPROCATING BLADE, DOUBLE SIDED, OFFSET (70.0 X 0.8 X 12.5MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP RECIPROCATING BLADE, DOUBLE SIDED, OFFSET (70.0 X 0.8 X 12.5MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL Back to Search Results
Model Number 0277096276
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/26/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The quality investigation is complete.
 
Event or Problem Description
It was reported that during testing the blade broke at the base.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
 
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Brand Name
RECIPROCATING BLADE, DOUBLE SIDED, OFFSET (70.0 X 0.8 X 12.5MM)
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 Key12033615
Report Number3015967359-2021-01192
Device Sequence Number4403791
Product Code GFA
UDI-Device Identifier04546540880673
UDI-Public04546540880673
Combination Product (Y/N)N
Initial Reporter StateCA
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
Type of Report Initial
Report Date (Section B) 06/21/2021
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 Number0277096276
Device Catalogue Number0277096276
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2021
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/26/2021
Initial Report FDA Received Date06/21/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
8206000000, SYSTEM 8 RECIP SAW, S/N: (B)(4)
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