MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC SILO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	8880009
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare professional via a manufacturer representative regarding a patient with preoperative diagnosis for l1 vertebral fracture.Procedure performed was posterior fusion for l1 fracture.The level at which the implant performed was th11-l3.It was reported that the torque limiting handle was broken during the final tightening.When final tightening was performed starting from the right temporal side, the product was broken when the third l2 was finally tightened.As a replacement, the final tightening was done using a modular fix handle & torque indicating driver, and the operation was completed without any problems.There was no fragment left inside the patient.There was no patient symptoms or complications as a result of this event.Delay in overall procedure time was less than 60 minutes.
Additional Manufacturer Narrative
H3.Product analysis product id # 8880009 lot no.# bm12e007 visual inspection confirmed the torque handle has broken at the weld.The damage appears to be from overload caused from excessive force placed on the handle during use.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SILO
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 19170485
• Report Number: 1030489-2024-00320
• Device Sequence Number: 7855746
• Product Code: LXH
• UDI-Device Identifier: 00885074226552
• UDI-Public: 00885074226552
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2024

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: 8880009
• Device Catalogue Number: 8880009
• Device Lot Number: BM12E007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 04/24/2024
• 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