MAUDE Adverse Event Report: STRYKER GMBH DIRECT MEASURING GAUGE ASNIS III FOR WIRES: Ø3.0/3.2X300MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	702495
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	Pain (1994); Perforation (2001)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "an excessively long asnis screw was selected, and it pierced the head of the collum.The patient is in pain and says that the specialist used screws that were too long.The specialist says that it is due to the stryker measuring instrument.The screw was revised on (b)(6)".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "an excessively long asnis screw was selected, and it pierced the head of the collum.The patient is in pain and says that the specialist used screws that were too long.The specialist says that it is due to the stryker measuring instrument.The screw was revised on (b)(6).".
Additional Manufacturer Narrative
Please note the corrections to d9, h6 method, results and conclusion codes.The reported device malfunction could not be confirmed post-operative x-ray images have been received.It could be confirmed that one implanted screw is too long, as it perforated the femoral head.However, there is no evidence confirming the reported instrument-related impaired measuring.The device inspection revealed the following: the identification of the returned measuring gauge could be confirmed based on the catalog number and lot number marked.No damage was observed on the device.The graduation is clearly visible.The returned measuring gauge and guide wire were tested, no malfunction was observed.Dimensional inspection showed the device to be within specification.It must be noted that the device has been in use for 7 years and no similar complaint has been previously reported for the same lot.The root cause of the incident could not be determined during the investigation.Any instrument-related could be ruled out.The return of the second screw would have been necessary for a complete investigation and to determine the exact cause.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 more information is provided, the case will be reassessed.

• Brand Name: DIRECT MEASURING GAUGE ASNIS III FOR WIRES: Ø3.0/3.2X300MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 23818249
• Report Number: 0008031020-2025-02163
• Device Sequence Number: 10098795
• Product Code: LXH
• UDI-Device Identifier: 04546540369154
• UDI-Public: (01)04546540369154(10)J03827
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 03/24/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 702495
• Device Lot Number: J03827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 75 KG