MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW VARIAX FULL THREAD 3.5MM / L24MM; PLATE, FIXATION, BONE

Catalog Number 614824

Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation, additional information will be provided in a supplemental report.

Event Description

Plastic particles where found at the screw.

Manufacturer Narrative

The reported event could be confirmed, since some unidentified particles have been found on the screw shafts, just below the screw heads.The screws were returned and analyzed under a microscope.The reported event could be confirmed since a white, spider-web like material is indeed deposited on the screw shaft.The material in question could not be identified from the pictures alone.Since it was not possible to determine the nature of the particles internally, the screws were sent to an independent external lab for further analysis.The final report of the analysis states that the residues were examined under sem, which determine that their structure was one of fibers.Using edx, it was detected that these fibers were made of carbon and oxygen.Further research proved that these structures were similar to similar to cotton.Cotton has a large amount of cellulose, and cellulose is an organic molecule containing mainly carbon and oxygen.The final conclusion of the report thus identified the residues to be cotton.The most probably root cause to the reported event is thus that some kind of medical dressing (very usually made out of cotton) in the hospital was forgotten in the tray containing the screws, and got washed away in the cleaning and sterilization process, causing cotton particles to spread and end up on various products, including the reported screws.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 investigation report will be updated.

Event Description

Plastic particles where found at the screw.

• Brand Name: BONE SCREW VARIAX FULL THREAD 3.5MM / L24MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8434715
• MDR Text Key: 139311745
• Report Number: 0008031020-2019-00280
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613154970322
• UDI-Public: 07613154970322
• Combination Product (y/n): N
• PMA/PMN Number: K101056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 614824
• Device Lot Number: V03468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Date Manufacturer Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1