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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/L18MM; SCREW, FIXATION, BONE
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STRYKER GMBH LOCKING SCREW,T8 FULL THREAD, 2.7MM/L18MM; SCREW, FIXATION, BONE Back to Search Results
Catalog Number 656318
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/12/2019
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.Device disposition is unknown.
 
Event or Problem Description
It was reported that when implanting a variax 2 distal radius plate, the locking screw did not lock into the plate.Another screw was used and locked into the plate successfully.Surgery was completed with a surgical delay of less than 2 minutes.
 
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Brand Name
LOCKING SCREW,T8 FULL THREAD, 2.7MM/L18MM
Common Device Name
SCREW, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key8406062
Report Number0008031020-2019-00176
Device Sequence Number420397
Product Code HWC
UDI-Device Identifier07613327068696
UDI-Public07613327068696
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) 03/08/2019
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 Number656318
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/12/2019
Initial Report FDA Received Date03/08/2019
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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