MAUDE Adverse Event Report: STRYKER GMBH PLATE TRIAL VARIAX FOR SUP. PLATE INCREASED&; TEMPLATE

Catalog Number	703841
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: ''the products have surface abnormalities (corrosion).''.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The device was not returned for evaluation.The reported event could be confirmed based on the photo received.The device was not returned.However, a photo confirming the reported event was received.In the photo, surface abnormality, most probably corrosion, can be seen on four plates.Only the back of the plates was visible in the photo, hence, the lot # could not be identified.Despite the requests made, the number of cleaning/sterilization cycles the devices underwent, as well as the method and products used for cleaning/sterilization were not communicated.Such information and the return of the devices would have been essential to determine the root cause of the reported event.Without more accurate information, a detailed investigation was not possible.It must be noted that the instructions for use and the instructions for cleaning, sterilization, inspection and maintenance clearly indicate the method, the products and the steps required for successful cleaning and sterilization of such devices.If these instructions are followed correctly, corrosion is unlikely to occur, regardless of the number of cycles.Furthermore, it must be noted that no similar complaint has been previously reported for such devices.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.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported : ''the products have surface abnormalities (corrosion).''.
Additional Manufacturer Narrative
The device was not returned for evaluation.The reported event could be confirmed based on the photo received.The device was not returned.However, a photo confirming the reported event was received.In the photo, surface abnormality, most probably corrosion, can be seen on four plates.Only the back of the plates was visible in the photo, hence, the lot # could not be identified.Despite the requests made, the number of cleaning/sterilization cycles the devices underwent, as well as the method and products used for cleaning/sterilization were not communicated.Such information and the return of the devices would have been essential to determine the root cause of the reported event.Without more accurate information, a detailed investigation was not possible.It must be noted that the instructions for use and the instructions for cleaning, sterilization, inspection and maintenance clearly indicate the method, the products and the steps required for successful cleaning and sterilization of such devices.If these instructions are followed correctly, corrosion is unlikely to occur, regardless of the number of cycles.Furthermore, it must be noted that no similar complaint has been previously reported for such devices.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.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported : ''the products have surface abnormalities (corrosion).''.

• Brand Name: PLATE TRIAL VARIAX FOR SUP. PLATE INCREASED&
• Common Device Name: TEMPLATE
• 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 Key: 19862193
• Report Number: 0008031020-2024-00284
• Device Sequence Number: 15481661
• Product Code: HWT
• UDI-Device Identifier: 04546540703910
• UDI-Public: 04546540703910
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 703841
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown