MAUDE Adverse Event Report: STRYKER GMBH SUPERIOR LATERAL PLATE VARIAX CLAVICLE 5 HOLE / LEFT; PLATE, FIXATION, BONE

Model Number	628205
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The variax clavicle plate did not succeed in fixing the fracture.It looks as if the screws (bone and locking screws) dislocated from the plate.
Event or Problem Description
The variax clavicle plate did not succeed in fixing the fracture.It looks as if the screws (bone and locking screws) dislocated from the plate.
Additional Manufacturer Narrative
The reported event could be confirmed.The x-rays were received and reviewed by stryker's medical expert.The medical opinion is the following: " this is an unstable clavicular fracture.Looking at the x-rays taken post-operatively it looks like the most medial screw is rather short (maybe did not penetrate the second cortex, or did not go through the middle of the bone).The other two medial screws do not look like they are locked into the plate properly.The screw head is visible above the plate.This means that these are prone to break out under severe stress.The patient has dementia (not having the information how severe it is), but it is a big risk factor.These patients are hard to give instructions and should be monitored the entire day.It may be possible that this patient used both hands to get out of a chair, this could put large stress on the construction that the plate pulls out the screws, it might have happened as well when locked if the forces applied on the construction were high enough.Looking at the dislocation something must have happened, at least some force to cause this failure." therefore, based on investigation, the root cause was attributed to a user/patient related issue.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.

• Brand Name: SUPERIOR LATERAL PLATE VARIAX CLAVICLE 5 HOLE / LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10688279
• Report Number: 0008031020-2020-02328
• Device Sequence Number: 11501451
• Product Code: HRS
• UDI-Device Identifier: 07613252442288
• UDI-Public: 07613252442288
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K113760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: 628205
• Device Catalogue Number: 628205
• Device Lot Number: Y45878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR