MAUDE Adverse Event Report: STRYKER SPINE-US STRAIGHT AWL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48019101
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Vascular Dissection (3160)
Date of Event	07/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported that while the surgeon was removing a monterey straight awl from a patient, the device nicked a blood vessel which led to major blood loss.It was further reported that a mass blood transfusion protocol was performed to stabilize the patient and that the blood vessel was closed.This resulted in a 180 minute surgical delay, and the procedure was unable to be completed as planned.It is currently unknown if the procedure will be rescheduled.
Additional Manufacturer Narrative
Corrected data: b1.Additional data: b5.H6 coding has been updated to reflect additional information received.
Event or Problem Description
A company representative reported that the procedure was completed one week later.It was further reported that the awl functioned as intended and that the difficult patient anatomy and handling of the device led to the contact with the blood vessel.The patient is reported to be doing well with no pain.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
No new information.

• Brand Name: STRAIGHT AWL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: matthew kelleher ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 22923908
• Report Number: 0009617544-2025-00070
• Device Sequence Number: 13051929
• Product Code: LXH
• UDI-Device Identifier: 07613327456073
• UDI-Public: 07613327456073
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2026

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: 48019101
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 09/25/2025; 11/26/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/24/2025; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 48 YR
• Patient Sex: Female