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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., AGG. PLUS SHAVER BLADE, INJECTION F-SERIES - 3.5MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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STRYKER ENDOSCOPY-SAN JOSE PKG., AGG. PLUS SHAVER BLADE, INJECTION F-SERIES - 3.5MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL Back to Search Results
Catalog Number 0375534000
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/30/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: inside part broke off mid shaft.Probable root cause: deformed cutter teeth.Incorrect gap between cutter/housing.No/minimal clearance between cutter and housing.Excessive runout.Excessive wear/gall.Incorrect diamond grit size/ type and coating process.The device manufacture date is not known.
 
Event or Problem Description
It was reported that the device broke during a procedure.All pieces were retrieved.
 
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Brand Name
PKG., AGG. PLUS SHAVER BLADE, INJECTION F-SERIES - 3.5MM
Common Device Name
BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key7907626
Report Number0002936485-2018-00624
Device Sequence Number16480568
Product Code GFA
UDI-Device Identifier37613327061742
UDI-Public37613327061742
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
Type of Report Initial
Report Date (Section B) 09/25/2018
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 Catalogue Number0375534000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/30/2018
Initial Report FDA Received Date09/25/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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