MAUDE Adverse Event Report: OSTEOCENTRIC TECHNOLOGIES, INC. 2.5MM DRILL BIT CALIBRATED 200MM; 2.5MM DRILL 200MM, CALIBRATED DRILL BIT

Model Number	110040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 2.5mm calibrated drill bit was being used for a pelvis surgery and broke during use.The surgeon was observing his fellow when the drill bit broke.The part was discarded and the surgeon admitted it was user error where the brill bit was being used beyond its mechanical limits.
Event or Problem Description
It was reported that a 2.5mm calibrated drill bit part # 110040 lot# cal008 was being used for a pelvis surgery and broke off in a patient.The remaining drill bit was discarded.
Additional Manufacturer Narrative
Udi related data quality updates, product information update, & initial reporter updates: this follow-up report includes the addition of the brand name, model number, full udi, and 510(k) number, which were missing from the initial report.The lot # and manufacturing date are on the device label, but are not on the label as a pi.This report specifies that this is not a combination product.This report adds the manufacture date and that the product is for single use.Additionally, this report updates the initial reporter information to the physician who initially reported the issue.

• Brand Name: 2.5MM DRILL BIT CALIBRATED 200MM
• Common Device Name: 2.5MM DRILL 200MM, CALIBRATED DRILL BIT
• Manufacturer (Section D): OSTEOCENTRIC TECHNOLOGIES, INC.; 75 w 300 n; suite 150; logan UT 84321
• Manufacturer (Section G): OSTEOCENTRIC TECHNOLOGIES, INC.; 75 w 300 n; suite 150; logan UT 84321
• MDR Report Key: 18279476
• Report Number: 3011656326-2023-00003
• Device Sequence Number: 17708256
• Product Code: HTW
• UDI-Device Identifier: 00816950028373
• UDI-Public: (01)00816950028373
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K152000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2023

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: Health Professional
• Device Model Number: 110040
• Device Catalogue Number: 110040
• Device Lot Number: CAL008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown