MAUDE Adverse Event Report: STRYKER SPINE-US TRITANIUM TL INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48930000
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the locking mechanism on a tritanium tl steerable inserter was jamming during cage insertion intra-operatively.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Event or Problem Description
A company representative reported that the locking mechanism on a tritanium tl steerable inserter was jamming during cage insertion intra-operatively.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Additional data: h3.H6 coding has been updated to reflect completion of the investigation.

• Brand Name: TRITANIUM TL INSERTER
• 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: catherine devarenne ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 24867571
• Report Number: 0009617544-2026-00064
• Device Sequence Number: 15939307
• Product Code: LXH
• UDI-Device Identifier: 07613327370096
• UDI-Public: 07613327370096
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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: 48930000
• Device Lot Number: 183027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2019
• 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
• Patient Sex: Unknown