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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider via a manufacturer representative regarding an instrument used for microdiscectomy therapy.It was reported that during the discectomy the instrument got damage.There was no patient involved in the event.There was no fragment left in the patient.The event was happened at the time of surgery only.When the instrument suddenly stopped working than surgeon noticed that the tip was broken.Surgeon tried to find that broken piece first into the patient through intra-op carm scans or radiologic images but could not find anything in the patient.Patient is absolutely fine <(>&<)> safe.

• 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
• MDR Report Key: 12611939
• Report Number: 1030489-2021-01261
• Device Sequence Number: 1415165
• Product Code: LXH
• UDI-Device Identifier: 00885074451220
• UDI-Public: 00885074451220
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/12/2021

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: GZ19E024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2021
• Initial Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1