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

Catalog Number 5401-84500H

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 10/14/2016

Event Type  malfunction  

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 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
• Type of Device: BONE FIXATION CERCLAGE
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: sandra gilbert ; 600 hope parkway se; leesburg, VA 20175 ; 5719192000
• MDR Report Key: 6101512
• MDR Text Key: 59858048
• Report Number: 3004774118-2016-00095
• Device Sequence Number: 1
• Product Code: OWI
• UDI-Device Identifier: 10888857157682
• UDI-Public: 10888857157682
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143350
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 5401-84500H
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: (B)(4) LOT UNKNOWN; (B)(4) LOT UNKNOWN
• Patient Age: 10 YR