MAUDE Adverse Event Report: ARTHREX, INC. PRFL DRL, 5.0MM LG CMPR FT SCRW, REUSE; DRILL BIT

Model Number	PRFL DRL, 5.0MM LG CMPR FT SCRW, REUSE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a surgery the profile drill broke during drilling and two parts broke off.All fragments were retrieved from the patient.The surgeon continued inserting the screw without more drilling.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint allegation is confirmed.Upon visual inspection, it was noted that the flutes of the profile drill for 5.0 large compression ft screws, reusable had broken off and bent.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to either excessive force used, misaligned insertion or the device coming in contact with another device during use.

• Brand Name: PRFL DRL, 5.0MM LG CMPR FT SCRW, REUSE
• Common Device Name: DRILL BIT
• 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: jared engle ; 8009337001
• MDR Report Key: 21042004
• Report Number: 1220246-2024-09132
• Device Sequence Number: 18291253
• Product Code: HTW
• UDI-Device Identifier: 00888867319578
• UDI-Public: (01)00888867319578(11)191014(10)021941
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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: PRFL DRL, 5.0MM LG CMPR FT SCRW, REUSE
• Device Catalogue Number: AR-8750-05-RU
• Device Lot Number: 021941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown