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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH ONE-THIRD TUBULAR PLATE VARIAX2 5 HOLE / L59MM; PLATE, FIXATION, BONE
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STRYKER GMBH ONE-THIRD TUBULAR PLATE VARIAX2 5 HOLE / L59MM; PLATE, FIXATION, BONE Back to Search Results
Model Number 626675
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)
Event Date 09/09/2020
Event Type  Injury  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
As reported: "patient undergoing surgical treatment shortening of the ulnar in order to treat ulno-carpal impact for 45 days.Patient underwent weekly follow-up with frequent radiographs, the last one on (b)(6) 2020 - observing osteotomy without signs of consolidation and synthesis material without signs of failure, however the x-ray performed on (b)(6) 2020 presented osteotomy without signs of consolidation and failure of the synthesis material.Held on (b)(6) 2020, emergency procedure for new fixation of the osteotomy focus and replacement of the synthesis material with fracture.During the procedure, intense metallosis + fracture of the plate 1/3 tube was observed in a titanium of 5 holes, through its 3 hole in the proximal fragment of the mentioned patient's ulna.In the follow-up of the patient, she did not report any new traumas or major physical effort that would justify such an event, since the patient is awaiting evaluation and diagnosis of the synthesis material in question.".
 
Manufacturer Narrative
The reported event could be confirmed, since the device was returned and matches the event description.The visual inspection of the device shows that the plate and 5 locking screws were returned.The plate broke at the level of the 3rd (middle) hole.The 5 screws are functional.A microscope analysis of the surface of the breakage shows bright surfaces specific to fatigue fractures.Indeed, the shiny metal is a result of the two bridges of the plate rubbing against each other for multiple cycles before completely breaking.Based on investigation, the root cause of the breakage was attributed to a fatigue issue.The failure was caused by the application of a persistent mechanical loading on the device, resulting in the fatigue of the material.Furthermore, the opinion of a medical expert was requested to clarify the metallosis reported.Their statement is the following: "[.] the literature talks about the varying corrosive effects of anodized titanium, relating to the thickness and color of the anodized layers.At a fracture site, wolff¿s law is occurring with a generation of an electrical current, although very slight, the current occurs within the solutions around the plate and soft-tissue and will corrode to metal surface.It is the interaction of an inorganic material in titanium plates, and soft tissue and the degree of roughness of the implant surface, the methods utilized in achieving the surface topography, and the chemistry of implant materials (titanium), are some of the factors that may affect the soft tissue response of the plate to the adjacent soft tissue and create the grayish color.There has been no risk reported with this corrosive action since the levels of local metal ions and systemic ions is usually at very low levels in these cases.In case of high levels of metal ions, risks have been reported associated with local soft tissue damage, delayed hypersensitivity reaction (type iv) and systemic toxicity.[.]" based on this statement, the metallosis is a patient related issue that results from how the patient responds to the implants.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 any further information is provided, the complaint report will be updated.
 
Event Description
As reported: "patient undergoing surgical treatment shortening of the ulnar in order to treat ulno-carpal impact for 45 days.Patient underwent weekly follow-up with frequent radiographs, the last one on (b)(6) 2020 - observing osteotomy without signs of consolidation and synthesis material without signs of failure, however the x-ray performed on (b)(6) 2020 presented osteotomy without signs of consolidation and failure of the synthesis material.Held on (b)(6) 2020, emergency procedure for new fixation of the osteotomy focus and replacement of the synthesis material with fracture.During the procedure, intense metallosis + fracture of the plate 1/3 tube was observed in a titanium of 5 holes, through its 3 hole in the proximal fragment of the mentioned patient's ulna.In the follow-up of the patient, she did not report any new traumas or major physical effort that would justify such an event, since the patient is awaiting evaluation and diagnosis of the synthesis material in question.".
 
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Brand Name
ONE-THIRD TUBULAR PLATE VARIAX2 5 HOLE / L59MM
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ  2545
MDR Report Key10667378
MDR Text Key211056459
Report Number0008031020-2020-02319
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07613327088656
UDI-Public07613327088656
Combination Product (y/n)N
PMA/PMN Number
K151879
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number626675
Device Catalogue Number626675
Device Lot NumberD12474
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2020
Date Manufacturer Received12/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age46 YR
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