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

Model Number	9569567
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information received from healthcare provider via manufacturer representative regarding an event happened during intra-op for a patient undergoing microdiscectomy procedure.The pre-op diagnosis was mentioned as m51.26 left l5-s1 herniated disc.It was reported that, the piece that broke was left in the patient.Two micro pituitaries broke during the procedure and both tips were left in the patient.Surgeon decided that trying to remove the piece could cause more damage than leaving it in the patient.There were no symptoms to patient or physician were reported.There was no additional surgery or treatment performed as a result of this event.No further complications reported.
Additional Manufacturer Narrative
Radiographic image review result: intra-op images for l5-s1 metrx discectomy.Images show a radio-opaque body in the disc space.This is a piece of a micro pituitary by description.If information is provided in the future, a supplemental report will be issued.

• Brand Name: METRX II
• 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: 12959465
• Report Number: 1030489-2021-01526
• Device Sequence Number: 1728356
• Product Code: LXH
• UDI-Device Identifier: 00885074451220
• UDI-Public: 00885074451220
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2021

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: 9569567
• Device Catalogue Number: 9569567
• Device Lot Number: GZ16F012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 12/08/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 124 KG