MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY PIONEER SURGICAL TECHNOLOGIES STREAMLINE MIS PEDICLE SCREW ASSAY; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 05-PA-75-50

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Device Handling Problem (3265)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2022

Event Type  malfunction  

Event Description

Surgalign fi associate forwarded the following, "the tulip on a 7.5x50mm streamline mis screw popped off the screw post-operatively and required a revision surgery.The only adverse affect is the patient had to have multiple surgeries.Original surgery (b)(6) 2022.Revision surgery (b)(6) 2022.

Manufacturer Narrative

The device was returned to resolve surgical for evaluation.The quality engineer who performed the inspection stated, "the head diameter on the two screws sent back with the complaint were measured.The print requirement is that the head diameters fall within.2965" and.2975".The head diameters were mic'd in several different places, and no measurement were found to be out of tolerance.Looking at the dhr for this batch in paper vision, it appears the head diameter stayed consistently around nominal during the order run.The ra value on the head diameter could not be measured because these screws were assembled, used in surgery, and then disassembled, so very little surface roughness is still present at this time.However, the dhr for the batch of screws was looked up in paper vision to see the recorded blast values.The values recorded for inspection were within tolerance.The print states that an ra value of 50-80 is acceptable, and the recorded values are 60 and 61.No dimensional issues are present on these screws.The two yokes returned with the complaint were inspected for critical features.Three features on these parts have been known to be critical to impingement performance: the shelf depth, the core housing diameter, and the.318" diameter.The shelf depth on the two yokes were measured at.3778"-.3781".Nominal for this dimension is.380" +-.006", so these are well within tolerance.The shelf diameters measured at.3806"-.381".Nominal for this feature is.380" +-.002", so these features were well within tolerance.The.318" diameter was inspected using gage pins, which is how it's checked during production.Both yokes passed the gage pin check, so the.318" dimension is within tolerance.After inspecting the returned product, it appears that these parts are conforming to the print for all features that can lead to head dissociation.Additionally, after looking at the dhr for this batch of screw assemblies, this batch was tested for impingement.All orders of mis assemblies (05-pa screws) go through the test lab for head dissociation testing to verify that they meet a certain threshold requirement.Four assemblies from this batch were tested in the test lab, and met the necessary requirements to pass.A known issue with the mis system is that screw heads can easily dissociate from the core/yoke if the surgeon does not follow the procedure correctly.The ifu states to back the screw out slightly once it's screwed all the way down.Failure to do this results in a situation where very slight applied torque using the instruments can cause the head to pop off.This is because the core cannot fully rotate around the screw head if the screw is not backed out, which creates a "pinch point".With the minimal information received regarding this complaint, this sounds like the most likely cause of the failure.

• Brand Name: PIONEER SURGICAL TECHNOLOGIES STREAMLINE MIS PEDICLE SCREW ASSAY
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY; 357 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY; 357 river park circle; marquette MI 49855
• Manufacturer Contact: cassy baij ; 357 river park circle; marquette, MI 49855 ; 9062269909
• MDR Report Key: 13888888
• MDR Text Key: 287851574
• Report Number: 1833824-2022-00025
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00191083019758
• UDI-Public: (01)00191083019758(10)399383
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 05-PA-75-50
• Device Catalogue Number: 05-PA-75-50
• Device Lot Number: 399383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other