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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/L20MM; SCREW, FIXATION, BONE
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STRYKER GMBH LOCKING SCREW,T8 FULL THREAD, 2.7MM/L20MM; SCREW, FIXATION, BONE Back to Search Results
Catalog Number 656320
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/22/2019
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.
 
Event or Problem Description
Primary procedure, right distal radius.It was reported that upon implantation, the surgeon reported the screw refused to lock into the plate.Another screw was implanted and locked as expected.Surgery was completed successfully with a surgical delay of approximately 45 seconds.Rep reported that no further information will be released by the hospital or surgeon.
 
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Brand Name
LOCKING SCREW,T8 FULL THREAD, 2.7MM/L20MM
Common Device Name
SCREW, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key8434676
Report Number0008031020-2019-00278
Device Sequence Number1785319
Product Code HWC
UDI-Device Identifier07613327068702
UDI-Public07613327068702
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) 03/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number656320
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/22/2019
Initial Report FDA Received Date03/19/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number0
Outcome Attributed to Adverse Event Other;
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