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

Catalog Number	5584099
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2017
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.
Event or Problem Description
It was reported that the patient underwent lumbar decompression/fusion at l2-pelvis during which the tip of the driver broke.During insertion of the iliac screw in sclerotic bone tip of the driver broke.No fragments remained inside the patient.No patient complication was reported.
Additional Manufacturer Narrative
Product analysis: visually confirmed approximately ~3mm of instrument tip has been broken off, consistent with interface during usage.Inspection of the shaft diameter and material hardness confirmed conformance to print specification.Optical examination of the fracture surface analysis identified a fairly flat fracture surface and circular material flow, consistent with torsional overload.The above findings are consistent with torsional overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNK
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 6566196
• Report Number: 1030489-2017-01229
• Device Sequence Number: 979221
• Product Code: LXH
• UDI-Device Identifier: 00643169163065
• UDI-Public: 00643169163065
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2018

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: 5584099
• Device Lot Number: NM14C048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 05/15/2017
• Supplement Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1