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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW,T8 FULL THREAD, 2.7MM/L16MM; SCREW, FIXATION, BONE
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STRYKER GMBH LOCKING SCREW,T8 FULL THREAD, 2.7MM/L16MM; SCREW, FIXATION, BONE Back to Search Results
Catalog Number 656316
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/12/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device evaluated by mfr: device was discarded.
 
Event or Problem Description
It was reported that, during a primary procedure for a left distal radius fracture, the locking screw would not lock, and kept spinning in the plate.Another screw was used and locked as intended.Surgery was completed successfully with a delay of less than five minutes.No adverse consequences were reported.
 
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Brand Name
LOCKING SCREW,T8 FULL THREAD, 2.7MM/L16MM
Common Device Name
SCREW, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key8862800
Report Number0008031020-2019-01008
Device Sequence Number19489143
Product Code HWC
UDI-Device Identifier07613327068689
UDI-Public07613327068689
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
K180500
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/05/2019
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 Number656316
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/12/2019
Initial Report FDA Received Date08/05/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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