MAUDE Adverse Event Report: PRECISION SPINE, INC SURELOK MINI POSTERIOR CERVICAL/UPPER; SCREWDRIVER

Catalog Number	04-9094
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other - evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
Event or Problem Description
It was reported that a procdure was performed on (b)(6) 2023, utilizing the reform pedicle screw system.During attempts to insert a lock screw, the tip of the cap screw inserter (04-9094) broke off.The broken tip was retrieved from the screw and the procedure was completed utilizing other instrumentation readily available in the set.There was no patient injury or delay to the procedure as a result of the malfunction.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2023, utilizing the reform pedicle screw system.During attempts to insert a lock screw, the tip of the cap screw inserter (04-9094) broke off.The broken tip was retrieved from the screw and the procedure was completed utilizing other instrumentation readily available in the set.There was no patient injury or delay to the procedure as a result of the malfunction.
Additional Manufacturer Narrative
H3 device evaluation - hexalobe tip portion not returned for evaluation.The surface of the returned portion at the point of fracture indicates a failure due to rotational shear overload.Review of device history records found twenty-four (24) pieces of lot 25352ps released for distribution on 8/12/2019 with no deviation or anomalies.Two-year complaint history reivew did not reveal a trend for reports of this nature for this part number.Given the age of instrument, 4+ years, it is determined that no corrective action is required; product exceeded its expected service life cycle.

• Brand Name: SURELOK MINI POSTERIOR CERVICAL/UPPER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 18314745
• Report Number: 3005739886-2023-00064
• Device Sequence Number: 12434910
• Product Code: HXX
• UDI-Device Identifier: 00840019920650
• UDI-Public: 00840019920650
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2023

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 Catalogue Number: 04-9094
• Device Lot Number: 25352PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2019
• 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