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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH TWIST DRILL, DIAM.1.4X87MM, WL 27MM, AO SHAFT END; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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STRYKER GMBH TWIST DRILL, DIAM.1.4X87MM, WL 27MM, AO SHAFT END; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Catalog Number 60-14326
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/02/2019
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.Instruments were disposed after the case.
 
Event or Problem Description
Doctor broke drill and screw driver blades were striping screw heads because they are old.Need replacements but surgery center has policy with vendors where they do not pay for drills or screw driver blades for consigned inventory.
 
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Brand Name
TWIST DRILL, DIAM.1.4X87MM, WL 27MM, AO SHAFT END
Common Device Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key8283528
Report Number0008031020-2019-00052
Device Sequence Number19310694
Product Code LXH
UDI-Device Identifier04546540246721
UDI-Public04546540246721
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/28/2019
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 Number60-14326
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/02/2019
Initial Report FDA Received Date01/28/2019
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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