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

Model Number	48930005
Medical Device Problem Codes	Difficult to Remove (1528); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tritanium tl inserter and inner shaft "no longer holds the implant and cannot be disassembled" intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully with an 8 minute surgical delay.This record captures the inner shaft.
Additional Manufacturer Narrative
No visual non conformities identified.The tip of the returned inserter would not rotate.Black locking wings are jammed and cannot be unlocked.Lubrication was applied to all lubrication holes.Black locking wings were able to be unlocked.Subsequently, inserter tip was able to rotate and the inner shaft was able to be removed from the inserter properly.Device history records were reviewed for this lot, no relevant manufacturing issues were identified.Complaint history records were reviewed for this lot, and similar complaints were identified.Device stg states: the joint of the tl steerable inserter inner shaft, black rotation wings and the locking knob interface must be lubricated prior to every use.Please see tl lubrication guide for full details (id #(b)(4)).The most likely cause of the reported event was determined to be lack of proper lubrication.After lubrication was applied to returned device it functioned as intended.
Event or Problem Description
It was reported that a tritanium tl inserter and inner shaft "no longer holds the implant and cannot be disassembled" intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully with an 8 minute surgical delay.This record captures the inner shaft.

• 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: 13267473
• Report Number: 0009617544-2022-00003
• Device Sequence Number: 1580185
• Product Code: LXH
• UDI-Device Identifier: 07613327370133
• UDI-Public: 07613327370133
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2022

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 Model Number: 48930005
• Device Catalogue Number: 48930005
• Device Lot Number: 18A509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 01/17/2022
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2019
• 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