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

Catalog Number	9569565
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Procedure: minimally invasive discectomy pre operative diagnosis: herniated disc it was reported that intra-op, handle of the product broke.The product came in contact with the patient.No fragment of the product remained in the patient body.No patient symptom and complication were reported at the event.
Additional Manufacturer Narrative
Visual inspection confirmed the handle of the (b)(6) is broken off at the base of the shaft.Optical examination revealed a quasi-brittle fracture, with fracture morphology suggesting a lateral direction of fracture.The location, direction and amount of force required in order induce fracture is consistent with lateral bend stress overload.The above observations are consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.

• 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: 7975976
• Report Number: 1030489-2018-01365
• Device Sequence Number: 19146152
• Product Code: LXH
• UDI-Device Identifier: 00885074451206
• UDI-Public: 00885074451206
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 12/17/2018

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 Catalogue Number: 9569565
• Device Lot Number: GZ14B027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR