MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW S.T. SPS Ø4.5X46MM; PLATE, FIXATION, BONE

Catalog Number	340646
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	09/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that: "i just received order (b)(4), and in the bag containing screw (b)(6), there was a live earwig-like insect.".
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned and matches the alleged failure.The device inspection revealed the following: the package was received, and a dead insect was found trapped under the label.There is a slight space being formed between the plastic packet and label from where the insect entered and got trapped.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.From the product inspection and feedback from manufacturing team it is evident that the incident occurred during storage and handling of the device but it can¿t be retraced, if the insect did move itself into the cavity of the label while it was in stryker control or after it left stryker control.Therefore, an exact root cause of the complaint event could not be established.If more information is provided, the case will be reassessed.
Event or Problem Description
The customer reported that : "i just received order (b)(4), and in the bag containing screw (b)(6), there was a live earwig-like insect.".

• Brand Name: CORTEX SCREW S.T. SPS Ø4.5X46MM
• Common Device Name: 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23211621
• Report Number: 0008031020-2025-01660
• Device Sequence Number: 15708117
• Product Code: HRS
• UDI-Device Identifier: 07613327081145
• UDI-Public: (01)07613327081145(10)AP0755
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K222381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: 340646
• Device Lot Number: AP0755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• 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
• Patient Sex: Unknown