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

Model Number OS900041-NS

Device Problems Corroded (1131); Material Erosion (1214); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2017

Event Type  malfunction  

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 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
• Type of Device: DRILL BIT
• Manufacturer (Section D): ORTHO SOLUTIONS UK LTD; unit 5; west station business park; maldon, essex ; UK
• Manufacturer (Section G): ORTHO SOLUTIONS UK LTD; unit 5; west station business park; maldon, essex ; UK
• Manufacturer Contact: jesin synthee ; unit 5; west station business park; maldon, essex ; UK
• MDR Report Key: 6908391
• MDR Text Key: 89627224
• Report Number: 3008951116-2017-00009
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 05055662956146
• UDI-Public: (01)05055662956146(10)1091648
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1