MAUDE Adverse Event Report: PRECISION SPINE, INC SURELOK MIS 3L; SCREWDRIVER

Catalog Number	63-9012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
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 procedure was performed by on (b)(6) 2023, in saudi arabia, utilizing the surlok mis 3l pedicle screw system.After inserting the screw, while pulling the perc screwdriver, short (63-9012) out, it got broken and small pieces stayed in the patient.The surgeon had to make an incision to take it out prior to closure and as a result there was a forty (40) minute delay to the procedure.This occurred on the final screw so no additional instrumentation was required following the malfunction of the driver.
Additional Manufacturer Narrative
H3 device evaluation - (b)(6) (collar, perc screw inserter) not returned for evaluation.However, the surface of the returned portion indicates a failure due to weld failure.Given the age of instrument, 7+ years, it is determined that no corrective action is required; product exceeded its expected service life cycle.Two-year complaint history review ((b)(6) 2021-(b)(6) 2023) found this to be the only report of this nature for this part number.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2023, utilizing the surlok mis 3l pedicle screw system.After inserting the screw, while pulling the perc screwdriver, short (b)(6) out, it got broken and small pieces stayed in the patient.The surgeon had to make an incision to take it out prior to closure and as a result there was a forty (40) minute delay to the procedure.This occurred on the final screw so no additional instrumentation was required following the malfunction of the driver.

• Brand Name: SURELOK MIS 3L
• 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: 18251243
• Report Number: 3005739886-2023-00063
• Device Sequence Number: 7116915
• Product Code: HXX
• UDI-Device Identifier: 00840019919920
• UDI-Public: 00840019919920
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 63-9012
• Device Lot Number: 1183FR-R02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown