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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH ANTERIOR LATERAL PLATE VARIAX CLAVICLE 8 HOLE; PLATE, FIXATION, BONE

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STRYKER GMBH ANTERIOR LATERAL PLATE VARIAX CLAVICLE 8 HOLE; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 628408
Device Problem Material Fragmentation (1261)
Patient Problems Discomfort (2330); Foreign Body In Patient (2687)
Event Date 09/01/2022
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
It was reported that during a variax clavicula plate removal, whilst removing the screws and plate the surgeon noticed some metal particles in the wound.He reported the case to the head nurse and gave her all implants (plates + screws).
 
Manufacturer Narrative
The reported event that could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received plate shows signs of usage as the holes of the plate were found deformed along with dents and scratches all over the plate.Some of the holes shows severe damage which indicate towards the possible misalignment of the screws most likely while insertion of the plate.Other than these no other significant damages were found.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause was attributed to a user-related issue.The revision of the plate and screws was most likely caused due to intraoperative misalignment of some of the screws onto the plate during insertion which in turn caused stripping/fragmentation of the screw threads.This malalignment may have led to the alleged discomfort in subsequent days.If any further information is provided, the complaint report will be updated.
 
Event Description
It was reported that during a variax clavicula plate removal, whilst removing the screws and plate the surgeon noticed some metal particles in the wound.Additional information: the reason for the removal of the plate was the discomfort it caused.There was no debris left in the patient.
 
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Brand Name
ANTERIOR LATERAL PLATE VARIAX CLAVICLE 8 HOLE
Type of Device
PLATE, 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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key16131183
MDR Text Key308489630
Report Number0008031020-2023-00012
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K113760
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 05/16/2023
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? Yes
Device Operator Health Professional
Device Catalogue Number628408
Device Lot NumberL13366
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/15/2022
Initial Date FDA Received01/10/2023
Supplement Dates Manufacturer Received04/20/2023
Supplement Dates FDA Received05/16/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age37 YR
Patient SexMale
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