MAUDE Adverse Event Report: STRYKER SPINE-US INSERTER TRITANIUM TL; 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	11/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during cage insertion a tritanium curved posterior lumbar cage became jammed and remained stuck to a tritanium steerable inserter and a tritanium steerable inserter shaft.The procedure was completed successfully using a replacement cage with a 25 minute surgical delay and no adverse consequence to the patient.This report captures the tritanium steerable inserter.
Additional Manufacturer Narrative
H3 other text : device was discarded.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.
Event or Problem Description
It was reported that during cage insertion a tritanium curved posterior lumbar cage became jammed and remained stuck to a tritanium steerable inserter and a tritanium steerable inserter shaft.The procedure was completed successfully using a replacement cage with a 25 minute surgical delay and no adverse consequence to the patient.This report captures the tritanium steerable inserter.

• 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: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 18311293
• Report Number: 0009617544-2023-00087
• Device Sequence Number: 6278598
• Product Code: LXH
• UDI-Device Identifier: 07613327370096
• UDI-Public: 07613327370096
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 03/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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