MAUDE Adverse Event Report: STRYKER GMBH 2.3 M VARIAX HAND LOCK 3-D PLATTE,4X2HOLES; PLATE, FIXATION, BONE

Model Number	57-15392
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	02/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "a variax hand plate was implanted 6 weeks ago.Skin irritation/inflammation occurred in the area of the plate.After treatment with cortisone failed, the surgeon removed the implants.".
Additional Manufacturer Narrative
Please note the correction to h6 device code.The reported event could not be confirmed, since no evidences were provided to confirm the reported failure mode.The device inspection revealed the following: the received plate was received in an undamaged state with normal signs of usage.The holes had usual deformation caused during screw insertion.However, the alleged issue does not necessitate a thorough device inspection.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Any documented or suspected material sensitivity is clearly contraindicated in the labelling.However, based on available information, the root cause was attributed to both a patient related and a user issue.The issue was caused by the patient intolerance to the material, and the lack of verification from the surgeon's part.It is the responsibility of the surgeon to check the allergies of a patient prior to the implantation.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "a variax hand plate was implanted 6 weeks ago.Skin irritation/inflammation occurred in the area of the plate.After treatment with cortisone failed, the surgeon removed the implants.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since no evidences were provided to confirm the reported failure mode.The device inspection revealed the following: the received plate was received in an undamaged state with normal signs of usage.The holes had usual deformation caused during screw insertion.However, the alleged issue does not necessitate a thorough device inspection.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.Any documented or suspected material sensitivity is clearly contraindicated in the labelling.Since the issue cannot be confirmed due to lack of evidence, a definitive root cause cannot be given.However, based on available information, the issue is most probably related to user and patient related factors.Probable factors include patient's intolerance to the material, and the lack of verification on the surgeon's part.It is the responsibility of the surgeon to check the allergies of a patient prior to the implantation.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "a variax hand plate was implanted 6 weeks ago.Skin irritation/inflammation occurred in the area of the plate.After treatment with cortisone failed, the surgeon removed the implants.".

• Brand Name: 2.3 M VARIAX HAND LOCK 3-D PLATTE,4X2HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; postfach; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13857964
• Report Number: 0008031020-2022-00124
• Device Sequence Number: 16494194
• Product Code: HRS
• UDI-Device Identifier: 07613154496761
• UDI-Public: 07613154496761
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K062498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2022

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: 57-15392
• Device Catalogue Number: 57-15392
• Device Lot Number: 1000442418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2022
• Supplement Date Received by Manufacturer: 06/10/2022; 08/26/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 06/17/2022; 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown