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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL LATERAL HUMERUS PLATE AXSOS 3 TI FOR LEFT HUMERUS 4 HOLE / L99MM PLATE, FIXATION, BONE

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STRYKER GMBH PROXIMAL LATERAL HUMERUS PLATE AXSOS 3 TI FOR LEFT HUMERUS 4 HOLE / L99MM PLATE, FIXATION, BONE Back to Search Results
Model Number 627204S
Device Problem Material Fragmentation (1261)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/02/2020
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
As reported: "event details: when fixing the screw to the plate, it was confirmed that there was metal lint. Physician's point of view: the screws were inserted at a difficult angle, so the metals rubbed against each other and were scraped. ".
 
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Brand NamePROXIMAL LATERAL HUMERUS PLATE AXSOS 3 TI FOR LEFT HUMERUS 4 HOLE / L99MM
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ 2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ 2545
Manufacturer Contact
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10339750
MDR Text Key200873947
Report Number0008031020-2020-01988
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07613327091106
UDI-Public07613327091106
Combination Product (y/n)N
PMA/PMN Number
K200398
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number627204S
Device Catalogue Number627204S
Device Lot NumberG14010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/26/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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