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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH PROFYLE DRILL, DIAM.2.0X105MM, WL 41MM, AO SHAFT END; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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STRYKER GMBH PROFYLE DRILL, DIAM.2.0X105MM, WL 41MM, AO SHAFT END; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Catalog Number 60-20385
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/23/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device was disposed.
 
Event or Problem Description
Pre-surgical check, patient was not in operating room at the time of discovery.Upon inspection, drill bit was found to not have been machined properly - some cutting flutes were missing or not properly spiraled.Hospital staff disposed of the device and rep has no pictures of it.
 
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Brand Name
PROFYLE DRILL, DIAM.2.0X105MM, WL 41MM, AO SHAFT END
Common Device Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key7895947
Report Number0008031020-2018-00618
Device Sequence Number169872
Product Code LXH
UDI-Device Identifier04546540247230
UDI-Public04546540247230
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
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) 09/20/2018
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 Number60-20385
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/23/2018
Initial Report FDA Received Date09/20/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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