MAUDE Adverse Event Report: MSD BARTLETT MFG OTHER INTRA-DISCAL INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	907350
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Device evaluation summary: product analysis # (b)(4):part # 907350 lot # cb05j020 visual and optical inspection confirmed the curette has broken at the handle shaft.The damage to the instrument is consistent overload.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from user facility via a manufacturer representative regarding the devices used for tlif procedure.It was reported that the handle of the instruments was bent and stripped.There was no patient involved.

• Brand Name: OTHER INTRA-DISCAL INSTRUMENTS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MSD BARTLETT MFG; 2975 brother blvd; bartlett TN 38133
• Manufacturer (Section G): MSD BARTLETT MFG; 2975 brother blvd; bartlett TN 38133
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 23461716
• Report Number: 1030489-2025-02554
• Device Sequence Number: 8945691
• Product Code: LXH
• UDI-Device Identifier: 00885074499499
• UDI-Public: (01)00885074499499(11)050901(10)CB05J020
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2025

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: 907350
• Device Catalogue Number: 907350
• Device Lot Number: CB05J020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2005
• 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