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

Model Number 48930005

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2022

Event Type  malfunction  

Event Description

This record is a consolidation of q3 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures one instance of intraoperative tritanium tl steerable inserter inner shaft jamming.The associated procedure was completed successfully with no surgical delay and no adverse consequence to the patient.

Event Description

This record is a consolidation of q3 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures one instance of intraoperative tritanium tl steerable inserter inner shaft jamming.The associated procedure was completed successfully with no surgical delay and no adverse consequence to the patient.

Manufacturer Narrative

Lot unknown (1): device not returned.

• Brand Name: STEERABLE INSERTER SHAFT
• Type of Device: 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: 15691427
• MDR Text Key: 302809338
• Report Number: 0009617544-2022-00097
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07613327370133
• UDI-Public: 07613327370133
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48930005
• Device Catalogue Number: 48930005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1