MAUDE Adverse Event Report: STRYKER GMBH ASNIS MICRO, CANNULATED SCREW, DIA. 3.0X20/5MM; SCREW, FIXATION, BONE

Catalog Number	40-30120
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Nausea (1970)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and, if received, will be provided in the supplemental report.
Event or Problem Description
It was reported that a patient contacted stryker to confirm the material composition of a 20mm partially threaded cannulated screw.The patient has a known cobalt allergy and is experiencing low blood pressure in the evenings, nausea after eating, and localized redness near the surgical site (without signs of infection).The patient is considering implant removal, but insurance will only cover the revision if cobalt exposure is confirmed, so they are requesting clarification on whether the screw contains cobalt or is pure titanium.
Additional Manufacturer Narrative
The reported event could not be confirmed since the affected device was not returned and no other evidence was shared for evaluation.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.More information as well as the affected device must be available in order to determine the exact root cause of the issue.The screw is manufactured from ti6al4v, a titanium alloy that does not contain cobalt part of its elemental composition.The standard elemental composition for this alloy is documented and available per the applicable material specifications.More detailed information regarding the complaint event, as well as additional device-specific details, is required to conduct a thorough investigation.Medical documentation such as pre-operative and post-operative notes, x-rays, and clinical records must be provided to support the assessment.The information currently available is insufficient, and the missing details are essential to determine the root cause of the complaint.If the device is received or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that a patient contacted stryker to confirm the material composition of a 20mm partially threaded cannulated screw.The patient has a known cobalt allergy and is experiencing low blood pressure in the evenings, nausea after eating, and localized redness near the surgical site (without signs of infection).The patient is considering implant removal, but insurance will only cover the revision if cobalt exposure is confirmed, so they are requesting clarification on whether the screw contains cobalt or is pure titanium.

• Brand Name: ASNIS MICRO, CANNULATED SCREW, DIA. 3.0X20/5MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach TN 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg TN D-791 11; GM D-79111
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23490591
• Report Number: 3010667733-2025-01292
• Device Sequence Number: 17301286
• Product Code: HWC
• UDI-Device Identifier: 07613154578047
• UDI-Public: 07613154578047
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 40-30120
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown