MAUDE Adverse Event Report: ORTHO SOLUTIONS UK LTD AO QC DRILL BIT 2.5/110/85 (GOLD); FLUTED SURGICAL DRILL BIT, SINGLE-USE, STERILE

Model Number	OS200125
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/27/2020
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.No anomalies or deviations were noted in the manufacture of this batch of drills which may have contributed to the failure of the drill bit during operation.Thus, the manufacture of the batch is therefore not likely to have been a cause for the drill fracture reported.The investigation was limited as there was a lack of clinical information, and the complaint device was discarded, thus not allowing for visual inspection or testing for material anomalies and insight into the mode of fracture.Although it was not possible to determine the root cause of failure, the failure rate for the product remains to be low and there were no issues found with the manufacture of the batch of drills.The os200125 drill and other ortho solutions drills sharing a similar design were found to be well-performing when compared to reported rates in literature.Based on the product failure rate and the results from the investigations conducted, there are currently no corrective actions to be taken.This complaint will however be monitored through ortho solution's post market surveillance procedures for re-occurrence and any evidence of negative trend.
Event or Problem Description
The drill fractured during surgery.A second drill of the same product code was used to complete the surgery.The surgery was completed successfully with minor delay caused.Most of the drill tip (the fluted section) remains inside the patient.The surgeon decided not to attempt to remove the broken drill section.No additional patient injury or complications were reported.

• Brand Name: AO QC DRILL BIT 2.5/110/85 (GOLD)
• 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: 9871745
• Report Number: 3008951116-2020-00004
• Device Sequence Number: 11580306
• Product Code: HTW
• UDI-Device Identifier: 05055662931105
• UDI-Public: (01)05055662931105(17)241201(10)1A2869
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K102743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/24/2020

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: 12/01/2024
• Device Model Number: OS200125
• Device Catalogue Number: OS200125
• Device Lot Number: 1A2869
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other