MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC TSRH 3DX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	8350393
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a manufacturer representative regarding a device used for spinal therapy.It was reported that the set screwdriver does not retain broken off set screws anymore.There was no patient involvement reported.There were no further complications reported regarding the event.Additional information was received from the manufacturer representative that for the drivers, both tips broke off.The tips were recovered and thrown away.The provisional driver was very dirty and could not be cleaned.The tube was old and has significant signs of wear from being used.
Additional Manufacturer Narrative
H3: product analysis #706396413:part # 8350393; lot # em10d064 visual and optical inspection confirmed the tip of the driver has broke.Optical inspection revealed a flat fracture surface with circular material flow.This type of damage is consistent with torsional 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.

• Brand Name: TSRH 3DX
• 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: 19401378
• Report Number: 1030489-2024-00579
• Device Sequence Number: 8394468
• Product Code: LXH
• UDI-Device Identifier: 00613994597793
• UDI-Public: 00613994597793
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/27/2024

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: 8350393
• Device Catalogue Number: 8350393
• Device Lot Number: EM10D064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 05/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2009
• 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