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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 03/26/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device evaluated by mfr: implanted in patient.
 
Event or Problem Description
It was reported that, during a primary procedure on a right distal radius, that two of the locking screws (a 16 and a 20) would not lock into the variax 2 plate.The screws kept spinning when fully implanted and could not be backed out.The surgeon decided to leave the screws in as non-locking screws.Surgery was completed successfully with a delay of approximately 2 minutes.
 
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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 Key8520379
Report Number0008031020-2019-00353
Device Sequence Number2798403
Product Code HWC
UDI-Device Identifier07613327068689
UDI-Public07613327068689
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
K180500
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/16/2019
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)Thirty-Day
Initial Date Received by Manufacturer 03/26/2019
Initial Report FDA Received Date04/16/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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