MAUDE Adverse Event Report: STRYKER GMBH LOWER TRAY 1 LEVEL; PLATE, FIXATION, BONE

Catalog Number 1500-0007

Device Problem Problem with Sterilization (1596)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2022

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported: "the ancillary equipment is very condensed, and when it was used in the operating room, there was water in the container, which led to a postponement of the operation this afternoon." additional information from customer: "the references of this device are euk-var2-t10-s-3 and euk-var2-clv-add-s-3.The patient underwent 2 anesthesia's in the same day.There was a 45 minute delay in the surgeon's operating schedule.The operating time of the procedure with the ready-to-use ancillary remained the same.No other consequences other than the sterilization protocol to be redone and the 2 anesthesia's for the patient.".

Event Description

As reported: "the ancillary equipment is very condensed, and when it was used in the operating room, there was water in the container, which led to a postponement of the operation this afternoon." additional information from customer: "the references of this device are euk-var2-t10-s-3 and euk-var2-clv-add-s-3.The patient underwent 2 anesthesia's in the same day.There was a 45 minute delay in the surgeon's operating schedule.The operating time of the procedure with the ready-to-use ancillary remained the same.No other consequences other than the sterilization protocol to be redone and the 2 anesthesia's for the patient.".

Manufacturer Narrative

The reported event could not be confirmed since the device was returned in dry condition for evaluation and no other evidences were provided.The device inspection revealed the following: the complained trays were returned for evaluation.The trays are in a dry condition and no humidity can be confirmed, which could be expected as the devices were reprocessed again after the event.In general are the devices in a good condition with no visible damages.Slight water stains are visible in some places, which is not uncommon.Different white stickers, that cover some of the vapor entry holes, are visible in different places on the trays.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.The complaint was forwarded to the sterility assurance department with following feedback: "the provided information states 134°c, 18min 30 => i assume that the "30" describes the drying time.In our ot-rg-1 it is mentioned several times that drying for the "detachable drawer trays" family can be more difficult and the drying process needs to be adjusted, e.G.Ot-rg-1 en rev.8 - page 18, notice, bullet point 4.It is recommended to increase the drying time to 45min or to separate the tray and sterilize it in two parts (detached).A wide variety of factors play a role, so a precise analysis is difficult.Influencing factors e.G.: sterilization fleece (in our validation we used steri sheet 100+, green, 66 g/m²), water and steam quality, steam generator, sterilizer, loading, cooling outside the chamber (air draft?), storage to the operating room, transport in the operating room, etc.In our internal validation, we formed and validated 2 worst case configurations from all components of the variax 2 compression plate and foot system, both sterilization and residual moisture.Both worst case trays weigh more than 11kg and consist of 4 levels.This tray consists of 3 levels and should not weigh more than 9kg.Since it does not represent the worst case compared to the tested samples, sufficient performance for drying can be assumed here.1) closing the vapor entry holes (outside and between levels) is counterproductive from a processing perspective.2) water marks are not uncommon.This can be related to the water quality and/or the sterilization is generally carried out using steam, which forms condensate on the product.Therefore, marks form depending on the water quality, which can also become more intense over time." no product related issue could be detected.As described above are there so many factors that have an influence on the outcome of the reprocessing process that it is not possible to define the root cause of the complained event afterwards.If more information is provided, the case will be reassessed.

• Brand Name: LOWER TRAY 1 LEVEL
• Type of Device: PLATE, FIXATION, BONE
• 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: 16000549
• MDR Text Key: 305682222
• Report Number: 0008031020-2022-00677
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1500-0007
• Device Lot Number: KMT112499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other