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

Model Number	110040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the investigation findings, potential cause can be attributed to unintended use error and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of osteocentric technologies quality process, all devices are manufactured, inspected, and released to approved specifications.
Event or Problem Description
It was reported that a 2.5mm calibrated drill bit part #110040 lot# dal008 was used to drill 3 pilot holes in the pelvis.On the third hole the drill bit tip broke off in the patient.The surgeon indicated he used a new drill and proper screw fixation proceeded.The surgeon indicated that he was using the drill outside of normal use.The remaining portion of the drill bit was discarded and therefore could not be returned for investigation.
Additional Manufacturer Narrative
Udi releated data quality updates, product information update, initial reporter updates, & report source update: 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 corrects the manufacture date.Additionally, this report updates the initial reporter information to the physician who initially reported the issue and includes the report source of how the issue became known by osteocentric technologies, inc.

• Brand Name: 2.5MM DRILL BIT CALIBRATED 200MM
• Common Device Name: 2.5MM X 200MM CALIBRATED DRILL BIT
• Manufacturer (Section D): OSTEOCENTRIC TECHNOLOGIES, INC.; 75 west 300 north; suite 150; logan UT 84321
• Manufacturer (Section G): OSTEOCENTRIC TECHNOLOGIES, INC.; 75 w 300 n; suite 150; logan 84321
• MDR Report Key: 18279295
• Report Number: 3011656326-2023-00002
• Device Sequence Number: 6667359
• Product Code: HTW
• UDI-Device Identifier: 00816950028373
• UDI-Public: (01)00816950028373
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Company Representative
• 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: DAL008
• 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: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• 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 Age: 47 YR
• Patient Sex: Female