MAUDE Adverse Event Report: PRECISION SPINE, INC SHURFIT MALIF SYSTEM; PADDLE SHAVER

Model Number	23-9029-03
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: primary unique device identified (udi) number - full udi number is not applicable for this product as it was manufactured prior to the implementation of udi requirements.H3: device evaluation - although information indicates that the product is available for evaluation, it has not be received to date.Review of device history records found six (6) pieces of lot: 1271im released for distribution on 3/19/2015 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.No corrective actions are recommended at this time.Should the product be received a follow-up medwatch report will be filed when the investigation is complete.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2026.During use, the cutting head portion of the paddle shaver 50mml x 10mmh (23-9029-03) broke off.The tip piece was easily removed and the procedure was completed successfully.There was no patient injury or delay the procedure.

• Brand Name: SHURFIT MALIF SYSTEM
• Common Device Name: PADDLE SHAVER
• 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: 24746828
• Report Number: 3005739886-2026-00020
• Device Sequence Number: 21123562
• Product Code: LXH
• UDI-Device Identifier: 00840019925310
• UDI-Public: 00840019925310
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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: 23-9029-03
• Device Catalogue Number: 23-9029-03
• Device Lot Number: 1271IM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2015
• 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