MAUDE Adverse Event Report: NEXTREMITY SOLUTIONS INCORE LAPIDUS; TARGETING GUIDE

Model Number	IC-LAP-0101L
Medical Device Problem Codes	Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
[(b)(4)].
Event or Problem Description
It was reported that, during a lapidus procedure of the 1st tmt joint, a drill bit seized in the targeting guide instrument.The targeting guide was removed and during the removal the surgeon stated that the medial cuneiform fractured distally into the fusion site.The removal of the instrument and the fractured cuneiform caused a 30-minute surgical delay.The fracture was plated as well as the lapidus procedure completed with a typical plate and screw approach without any subsequent issue.

• Brand Name: INCORE LAPIDUS
• Common Device Name: TARGETING GUIDE
• Manufacturer (Section D): NEXTREMITY SOLUTIONS; 210 n buffalo st; warsaw IN 46580
• MDR Report Key: 7706540
• Report Number: 3009540749-2018-00001
• Device Sequence Number: 13850313
• Product Code: HWC
• UDI-Device Identifier: 00817701021162
• UDI-Public: 00817701021162
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IC-LAP-0101L
• Device Catalogue Number: IC-LAP-0101L
• Device Lot Number: 1419804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 07/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 YR
• Patient Weight: 59