MAUDE Adverse Event Report: K2M, INC. NILE ALTERNATIVE FIXATION SYSTEM; BONE FIXATION CERCLAGE

Catalog Number	5401-84500H
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned to manufacturer for evaluation, and a thorough investigation could not be completed as the lot number has not been identified/confirmed in this case.Since the clamp was disposed of at the hospital, no physical, chemical evaluation could be performed, and the exact cause of the reported issue could not be ascertained.The difficulty with the nile clamp is consistent with improper technique.Tightening a set screw on a band and repositioning can cause stress risers in the band.While the implant was not returned, a general review of the manufacturing and inspection records revealed no additional information.Hospital disposed of device.
Event or Problem Description
It was reported to k2m, inc.On (b)(6) 2016 that a surgery took place on (b)(6) 2016 in which a nile clamp did not work as intended.

• Brand Name: NILE ALTERNATIVE FIXATION SYSTEM
• Common Device Name: BONE FIXATION CERCLAGE
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 6101512
• Report Number: 3004774118-2016-00095
• Device Sequence Number: 826681
• Product Code: OWI
• UDI-Device Identifier: 10888857157682
• UDI-Public: 10888857157682
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K143350
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/16/2016

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: Physician
• Device Catalogue Number: 5401-84500H
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2016
• Initial Report FDA Received Date: 11/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4) LOT UNKNOWN; (B)(4) LOT UNKNOWN
• Patient Age: 10 YR