MAUDE Adverse Event Report: ARTHREX, INC. 2.5MM DRILL BIT, CALIBRATED, REUSABLE; BIT, DRILL

Model Number	2.5MM DRILL BIT, CALIBRATED, REUSABLE
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitt.
Event or Problem Description
It was reported that during a distal radius fracture repair surgery a patient harm occurred when the screw broke the radius bone cortex.The harm occurred, because the 2.5 mm drill bit was too small for the 3.5 mm screws.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: 2.5MM DRILL BIT, CALIBRATED, REUSABLE
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 15137840
• Report Number: 1220246-2022-05323
• Device Sequence Number: 20267824
• Product Code: HTW
• UDI-Device Identifier: 00888867265653
• UDI-Public: 00888867265653
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/01/2022

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 Model Number: 2.5MM DRILL BIT, CALIBRATED, REUSABLE
• Device Catalogue Number: AR-8916-06-RU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 08/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown