MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L34MM; PLATE, FIXATION, BONE

Model Number	657334S
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
"it was reported that during surgery the nurse found the foreign material in the sterile pack for this item when they open the packaging.The foreign material was 4mm cubic, was seemed a rubber.The new screw was used for the surgery and it was successful.".
Additional Manufacturer Narrative
The reported event could not be confirmed.The part was received including the foreign material.Therefore, a ftir analysis was completed on the unknown contaminant on screw packaging.The top match to the contaminant of interest at a 93.42% match to ¿3m brand spray 80 rubber and vinyl adhesive¿.Stryker initiated a second ftir test with actual reference materials from the operation environment and the result differs from the result of the initial test performed on the contaminant.The ¿foreign material¿ was clearly linked to a latex material which is used typically in cleanrooms and or-environment.Based to the fact that the returned sample was opened it also has to be assumed that the latex particle source is from the or-environment.Therefore, the reported event is a user 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.
Event or Problem Description
"it was reported that during surgery the nurse found the foreign material in the sterile pack for this item when they open the packaging.The foreign material was 4mm cubic, was seemed a rubber.The new screw was used for the surgery and it was successful.".

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L34MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11121280
• Report Number: 0008031020-2021-00007
• Device Sequence Number: 4606894
• Product Code: HRS
• UDI-Device Identifier: 07613327087178
• UDI-Public: 07613327087178
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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 Expiration Date: 12/31/2023
• Device Model Number: 657334S
• Device Catalogue Number: 657334S
• Device Lot Number: Y57954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1