MAUDE Adverse Event Report: MSD BARTLETT MFG PYRAMID PLUS 4 ANTERIOR LUMBAR PLATE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	9870010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: evaluation of the returned device was not completed at the time of this report.A follow up report will be sent when analysis is complete.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 a healthcare facility via manufacturer representative regarding a driver used for spinal therapy.It was reported that the driver found broken.Product will be returned.There was no patient involved in the event.There were no further complications reported as a result of this event.Additional information received from manufacturer representative that upon the septic to sterilize for kcs would not sterilize it because it was broken.They removed it from the tray and turned it over to the following day.Comes out of pyramid tray for alifs.
Additional Manufacturer Narrative
H3: product analysis part # 9870010 lot # nm08k006 visual and optical inspection confirmed a section of the flex shaft has cracked/broken.The damage is consistent with bend stress overload.Additional information: g1, g3, h3, h6 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.

• Brand Name: PYRAMID PLUS 4 ANTERIOR LUMBAR PLATE
• 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: 19635253
• Report Number: 1030489-2024-00734
• Device Sequence Number: 20966267
• Product Code: LXH
• UDI-Device Identifier: 00613994284952
• UDI-Public: 00613994284952
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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: 9870010
• Device Catalogue Number: 9870010
• Device Lot Number: NM08K006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 07/23/2024
• 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
• Patient Sex: Unknown