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

Catalog Number	8110530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not 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
It was reported that, intra-op, the tip of the removal driver broke.Broken piece was retrieved from the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual review confirms angulated fracture of the tip of the driver.Microscopic examination of the fracture reveals an angulated quasi-brittle fracture, with no indication of fatigue, and river lines in the fracture surface suggest the possible direction of crack propagation.The above observations are consistent with bend stress overload as the mechanism of failure.The hardness of the driver meets print spec.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7395054
• Report Number: 1030489-2018-00506
• Device Sequence Number: 35766
• Product Code: LXH
• UDI-Device Identifier: 00721902744600
• UDI-Public: 00721902744600
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 10/05/2018

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: 8110530
• Device Lot Number: DD1834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 06/28/2018; 08/08/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 07/17/2018; 10/05/2018
• 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