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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG 2.3 M VARIAX HAND LOCK PLATE,STRAIGHT,16HOLES; PLATE, FIXATION, BONE
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STRYKER LEIBINGER FREIBURG 2.3 M VARIAX HAND LOCK PLATE,STRAIGHT,16HOLES; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 57-15316
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/17/2017
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed, any additional information will be reported in a supplemental report.
 
Event Description
On (b)(6) 2017, the patient suffered surgery for surgical correction of distal radius and 2nd metacarpal fractures.6 weeks after the surgery, the radiographs showed that the two plates had buckled, requiring revision surgery and implant of two new plates.The product will return to stryker.Patient with parkinson disease background.
 
Manufacturer Narrative
A review of the device history record showed that the device was manufactured according to specification.The identified deficiency of the scratches of the surfaces during the incoming inspection of the raw material are removed by the subsequent process steps and hence are unlikely to have an negative impact on the stability of the plates (scratches of course may negatively impact the stability of the plates, however, these surface scratches were removed).A root cause could not be identified with certainty.One reason is the lack of documentation of the state of the plate right after surgery and 6 week later at the revision surgery.Without this documentation, the impact on the plate between those two timestamps can not be determined exactly.Even so, the inspection of the device shows a rather extreme bending, which is unlikely to done intentionally by the surgeon.It is also unlikely that continous forces lead to the observed structure.Additionally, the second article (54-25279 - at the distal radius) is reported to be deformed as well, which hints to a larger event and not to a material/product issue.Even though we can not prove it, the most likeliest cause is a sudden force on the plate such as a small accident, (e.G.Falling over).There are no further information available from the customer to verify the claim.
 
Event Description
On (b)(6) 2017, the patient suffered surgery for surgical correction of distal radius and 2nd metacarpal fractures.6 weeks after the surgery, the radiographs showed that the two plates had buckled, requiring revision surgery and implant of two new plates.The product will return to stryker.Patient with parkinson disease background.
 
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Brand Name
2.3 M VARIAX HAND LOCK PLATE,STRAIGHT,16HOLES
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
Manufacturer (Section G)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6919474
MDR Text Key88439031
Report Number0008010177-2017-00252
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K062498
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 01/10/2018
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
Device Operator Lay User/Patient
Device Catalogue Number57-15316
Device Lot Number1000160498
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/13/2017
Initial Date FDA Received10/06/2017
Supplement Dates Manufacturer Received12/12/2017
Supplement Dates FDA Received01/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/11/2015
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 Age58 YR
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