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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X46MM TL15.5MM; SCREW, FIXATION, BONE
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STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X46MM TL15.5MM; SCREW, FIXATION, BONE Back to Search Results
Catalog Number 604646
Health Effect - Clinical Code Reaction (2414)
Date of Event 11/01/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Still implanted in patient.
 
Event or Problem Description
Complainant called on behalf of patient, stating patient had stryker screws and nails used in their broken ankle in (b)(6) 2018.Since this date, patient has been having allergic reactions and it has not yet been confirmed what is the cause.
 
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Brand Name
CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X46MM TL15.5MM
Common Device Name
SCREW, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key8605928
Report Number0008031020-2019-00496
Device Sequence Number16729215
Product Code HWC
UDI-Device Identifier04546540089816
UDI-Public04546540089816
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
K000080
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Catalogue Number604646
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/23/2019
Initial Report FDA Received Date05/13/2019
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 Required Intervention;
Patient Age32 YR
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