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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH ANTERIOR MIDSHAFT PLATE VARIAX CLAVICLE 10 HOLE PLATE, FIXATION, BONE

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STRYKER GMBH ANTERIOR MIDSHAFT PLATE VARIAX CLAVICLE 10 HOLE PLATE, FIXATION, BONE Back to Search Results
Catalog Number 628310S
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Information (3190)
Event Date 11/19/2018
Event Type  malfunction  
Manufacturer Narrative
The reported event that anterior midshaft plate variax clavicle 10 hole was alleged of 'breakage during surgery' could be confirmed. Based on investigation, the root cause was attributed to be user related. The failure was caused by too much mechanical force which was applied during plate bending. Note; the surgeon completed the case using the broken plate (in conjunction with a hook plate) as this appeared to be adequate for the patient. A review of the device history for the reported lot did not indicate any abnormalities. No corrective actions are required at this time. A review of the labeling did not indicate any abnormalities. No indications of material, manufacturing or design related problems were found during the investigation. If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
Event Description
The customer reported that during a variax case as he went to bend the 10 hole variax clavicle plate a piece snapped off the end while using the bender. The surgeon completed the case using the broken plate (in conjunction with a hook plate) as this appeared to be adequate for the patient.
 
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Brand NameANTERIOR MIDSHAFT PLATE VARIAX CLAVICLE 10 HOLE
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8171044
MDR Text Key131383777
Report Number0008031020-2018-01070
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K113760
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 12/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2021
Device Catalogue Number628310S
Device Lot NumberV31224
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 Received11/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/17/2016
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: 12/17/2018 Patient Sequence Number: 1
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