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

Catalog Number	48930000
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tritanium tl steerable inserter and a tritanium tl steerable inserter shaft were jamming intra-operatively and were unable to insert a cage.The procedure was completed successfully using different instruments with no surgical delay and no adverse consequence to the patient.This report captures the inserter.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Corrected data: g1.H6 coding has been updated to reflect completion of the investigation.

• Brand Name: INSERTER TRITANIUM TL
• 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: 23874055
• Report Number: 0009617544-2025-00129
• Device Sequence Number: 5520778
• Product Code: LXH
• UDI-Device Identifier: 07613327370096
• UDI-Public: 07613327370096
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 04/02/2026
• 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
• Patient Sex: Unknown