MAUDE Adverse Event Report: ORTHO SOLUTIONS UK LTD DRILL BIT 2.0MM X 123MM CALIBRATED; FLUTED SURGICAL DRILL BIT, SINGLE-USE, STERILE

Model Number	OS200020LC
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records confirmed that the product was supplied in conformance with ortho solutions specifications and no deviations or anomalies were identified in the manufacturing of the batch which may have contributed to the fracture.No tests on the complaint device could be conducted as the drill was not available to be returned.Trend analysis of the os200020lc drill has shown that the device is well-performing and no negative trend has been observed.Based on the clinical information provided regarding the surgical technique, a number of possibilities were identified which may have caused the failure of the drill bit.However, despite the findings from the investigation, a definitive root cause could not be determined.This is the 4th complaint for this product and based on the trend analysis, the failure rate is deemed to be low at (b)(4).Although it was not possible to determine the root cause of failure, there has been no indication of a new or emerging risk with this device, and no negative trend has been identified.Complaint condition has been identified as part of the risk assessment procedure, and no emerging or new risks have been identified.
Event or Problem Description
While the surgeon was drilling with the drill bit in right 1st mtj fusion procedure, it broke inside the patient and the fluted portion of the drill is embedded in the patient's bone.The surgeon decided that leaving it in would cause less harm.No additional patient injury or complications were reported.

• Brand Name: DRILL BIT 2.0MM X 123MM CALIBRATED
• Common Device Name: FLUTED SURGICAL DRILL BIT, SINGLE-USE, STERILE
• Manufacturer (Section D): ORTHO SOLUTIONS UK LTD; unit 5, west station business; spital road; maldon, essex CM9 6 FF; UK CM9 6FF
• MDR Report Key: 9883035
• Report Number: 3008951116-2020-00005
• Device Sequence Number: 14154182
• Product Code: HTW
• UDI-Device Identifier: 05055662930726
• UDI-Public: (01)05055662930726(17)220501(10)1088789
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/26/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2022
• Device Model Number: OS200020LC
• Device Catalogue Number: OS200020LC
• Device Lot Number: 1088789
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 03/26/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other