MAUDE Adverse Event Report: ORTHO SOLUTIONS UK LTD DRILL BIT FOR 8.0MM SCREW

Model Number	OS900041-NS
Medical Device Problem Codes	Corroded (1131); Material Erosion (1214); Device Operational Issue (2914)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was received regarding a residue found inside the cannulation of the drills.This residue was identified as rust.A series of tests were conducted to rule out and identify the root cause however it is yet to be determined.In the meantime a recall will be initiated to remove the products from the field while ortho solutions continues to investigate this complaint.Material chemical composition test and device history record review showed the product was made to approved specification.Further test were conducted on identification of residue via edx.Tests are also being conducted to re-check the suggested drying time for steam sterilisation validation.The reported temperature and timeline was already validated for this system via independent laboratory.Further report will be submitted when recall is initiated and/or root cause is identified.
Event or Problem Description
Brown residue was found inside the cannulation of the drills.It was found during cleaning and was not used on the patient.Ortho solutions have since conducted a series of test and the resiude was identified as early stage rust.Currently root case being investigated.

• Brand Name: DRILL BIT FOR 8.0MM SCREW
• Common Device Name: DRILL BIT
• Manufacturer (Section D): ORTHO SOLUTIONS UK LTD; unit 5; west station business park; maldon, essex ; UK
• MDR Report Key: 6908391
• Report Number: 3008951116-2017-00009
• Device Sequence Number: 19163605
• Product Code: HTW
• UDI-Device Identifier: 05055662956146
• UDI-Public: (01)05055662956146(10)1091648
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/29/2017

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: Other Health Care Professional
• Device Model Number: OS900041-NS
• Device Catalogue Number: N/A
• Device Lot Number: 1091648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2017
• Initial Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1