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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 RIGHT HUMERUS 3 HOLE / L86MM PLATE, FIXATION, BONE

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STRYKER GMBH PROXIMAL LATERAL HUMERUS PLATE AXSOS 3 TI FOR RIGHT HUMERUS 3 HOLE / L86MM PLATE, FIXATION, BONE Back to Search Results
Model Number 627233S
Device Problem Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Date 08/05/2021
Event Type  Injury  
Manufacturer Narrative

The device has not been returned. If additional information becomes available, it will be provided in a supplemental report.

 
Event Description

It was reported the holes for k-wire/suture on a stryker proximal humerus plate have a fiber wire torn/snapped. The device was implanted on tubercle minus to fix/fixate on the proximal humerus. The issue was observed during a revision surgery performed on (b)(6) 2021.

 
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Brand NamePROXIMAL LATERAL HUMERUS PLATE AXSOS 3 TI FOR RIGHT HUMERUS 3 HOLE / L86MM
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
kristen canter
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12377684
MDR Text Key268478799
Report Number0008031020-2021-00386
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeNL
PMA/PMN NumberK200398
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 08/27/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number627233S
Device Catalogue Number627233S
Device LOT NumberG26481
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/27/2021 Patient Sequence Number: 1
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