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

Model Number	23-9029-03
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a lateral fusion procedure was performed utilizing the shurfit malif interbody system.While using the paddle shaver 50mml x 10mmh (23-9029-03) to open the disc space the instrument snapped.The space was then opened with the 8mm shaver to retrieve the broken piece.It was confirmed by x-ray that the disc space was clear of all metal.The procedure was completed successfully with only a five (5) minute delay.
Additional Manufacturer Narrative
Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
Additional Manufacturer Narrative
H3 device evaluation - the paddle shaver fractured under rotational shear at the r.005 transition of the 10mm head.Very little bending load appears to be involved in the failure.No other damage is visible to the shaver.Failure can be attributed to a torsional overload applied during the rotation of the paddle shaver within the disc space.The 10mm shaver was too large for the disc space, resulting in an excessive amount of torque applied to fracture the shaver.Review of device history records found ten (10) pieces of lot 01380im released for distribution 6/30/2016 with no deviation or anomalies.Two-year complaint history review (6.21.2021-6.21.2023) found this to be the only report of this nature for any of the part numbers in the 23-9023-xx family during this two-year time frame.No corrective actions are recommended.
Event or Problem Description
It was reported that a lateral fusion procedure was performed by dr.Debiparshad, utilizing the shurfit plif interbody system.While using the paddle shaver 50mml x 10mmh (23-9029-03) to open the disc space the instrument snapped.The space was then opened with the 8mm shaver to retrieve the broken piece.It was confirmed by x-ray that the disc space was clear of all metal.The procedure was completed successfully with only a five (5) minute delay.

• 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: 17343315
• Report Number: 3005739886-2023-00034
• Device Sequence Number: 6548544
• Product Code: LXH
• UDI-Device Identifier: 00840019925310
• UDI-Public: 00840019925310
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 06/21/2023

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 Model Number: 23-9029-03
• Device Catalogue Number: 23-9029-03
• Device Lot Number: 01380IM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2016
• 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