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

Catalog Number 48930005

Device Problem Mechanical Jam (2983)

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

Event Date 11/27/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device was discarded.

Event 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 shaft.

Manufacturer Narrative

Corrected data: d9 / h3 additional data: d4, h4.

Event 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 shaft.

• 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: 18311286
• MDR Text Key: 330287660
• Report Number: 0009617544-2023-00086
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07613327370133
• UDI-Public: 07613327370133
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 48930005
• Device Lot Number: 194920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 03/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2020
• 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