MAUDE Adverse Event Report: STRYKER SPINE-US 5.5X40 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482615540
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the head of a xia serrato polyaxial screw was jammed intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
A visual inspection was performed.The tulip is seated higher on the shank than intended.Tulip was confirmed to be jammed on the screw shank bulb.A mallet impact onto the proximal end of the tulip dislodged the tulip and brought it back to a normal position and its normal range of polyaxiality.A screwdriver was able to properly engage screw after the tulip was returned to a normal position.Device history records were reviewed for this lot number, no relevant manufacturing issues were identified.Complaint history records were reviewed for this catalog number, no adverse trends were identified.No additional information was received from the field.The most likely cause of the reported event was determined to be due to the screw being over inserted.It is likely that during screw insertion the tulip was forced proximally on the screw shank by the bone which caused it to jam.This can occur if the screw is initially over inserted.
Event or Problem Description
It was reported that the head of a xia serrato polyaxial screw was jammed intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.

• Brand Name: 5.5X40 POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; SZ 2300
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13794950
• Report Number: 3005525032-2022-00008
• Device Sequence Number: 3892477
• Product Code: NKB
• UDI-Device Identifier: 07613327351842
• UDI-Public: 07613327351842
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K170496
• 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): 06/15/2022

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: 482615540
• Device Catalogue Number: 482615540
• Device Lot Number: C15073
• 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: 03/01/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown