MAUDE Adverse Event Report: STRYKER SPINE-US STEERABLE INSERTER SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48930005
Medical Device Problem Codes	Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that during insertion, the tritanium tl steerable inserter inner shaft would not release the tritanium tl cage.The procedure was completed successfully using a replacement device with no surgical delay and no adverse consequence to the patient.This report captures the tritanium tl steerable inserter inner shaft.
Event or Problem Description
A company representative reported that during insertion, the tritanium tl steerable inserter inner shaft would not release the tritanium tl cage.The procedure was completed successfully using a replacement device with no surgical delay and no adverse consequence to the patient.This report captures the tritanium tl steerable inserter inner shaft.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.

• Brand Name: STEERABLE INSERTER SHAFT
• 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: 18145342
• Report Number: 0009617544-2023-00072
• Device Sequence Number: 7502864
• Product Code: LXH
• UDI-Device Identifier: 07613327370133
• UDI-Public: 07613327370133
• 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
• Report Date (Section B): 02/16/2024

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: 48930005
• Device Lot Number: 17C628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2018
• 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
• Patient Sex: Female