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

Model Number	9569565
Medical Device Problem Codes	Difficult to Open or Close (2921); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis visual and optical examination identified that one of the handles of the instrument has been sheared off.The location and amount of force required in order induce fracture of the shaft is consistent with overload.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a consumer via field representative regarding a patient who undergone spinal therapy with an indication of radiculopathy.It was reported that during mis discectomy the scissors were deemed dull by the consumer and the micro pituitary didn¿t open and close like it should.Additionally, it was mentioned that the instruments not cutting/too dull.It was unknown whether the device was broken or not.No patient symptoms or complications as a result of this event.No treatment or additional surgery performed as a result of this event.Product utilized correctly according to the directions given in the ifu/labeling.No further complications were reported.Additional information received.It was reported that no cutting issues with the micro pituitary.The issue with that instrument was that it was sticking and not grabbing properly.Nothing broke and nothing left in patient.There was no major surgical delay.This product set has been in rotation for several months.No further complications were reported.

• Brand Name: METRX
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 11964001
• Report Number: 1030489-2021-00762
• Device Sequence Number: 16487508
• Product Code: LXH
• UDI-Device Identifier: 00885074451206
• UDI-Public: 00885074451206
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2021

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: 9569565
• Device Catalogue Number: 9569565
• Device Lot Number: GZ14B007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1