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

Catalog Number	8670087
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that patient presented with degenerative disc disease underwent lumbar decompression and fusion(minimally invasive approach) at l3-s1.Intra-op, tip of drill tap broke off.Tap immediately removed from surgical field and was replaced with another.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis result: visual microscopic hardness an approx.1.5mm section has broken off the tip of the tap.A microscopic review of the fracture face reveals a brittle fracture with rays emanating outward.This type of fracture is consistent with the material being overloaded by coming to a sudden stop during rotation.The hardness of the material was checked and meets print spec.The observations are consistent with torsional overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ORTHOPEDIC MANUAL 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: 7302980
• Report Number: 1030489-2018-00298
• Device Sequence Number: 1893112
• Product Code: LXH
• UDI-Device Identifier: 00885074445397
• UDI-Public: 00885074445397
• 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): 06/08/2018

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: 8670087
• Device Lot Number: IT16H007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Initial Date Received by Manufacturer: 02/02/2018
• Supplement Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1