MAUDE Adverse Event Report: ARTHREX, INC. LAG DRILL GUIDE, 3.5 MM / 2.5 MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	LAG DRILL GUIDE, 3.5 MM / 2.5 MM
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
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
On 07/15/2024, it was reported by a facility representative via sems-(b)(4) that an ar-8963-21 lag drill guide had a drill bit get stuck inside the tissue protector guide, which snapped when trying to remove the drill bit (photo attached).No pieces broke off inside the patient.The surgeon stated that the tissue protector guide was warped, which was what caused the drill bit to get stuck in the first place.The case was completed with no further information.This was discovered during an open reduction internal fixation, tarso metatarsal joint dislocation procedure on (b)(6) 2024, with no reported patient harm.Additional information was received on 7/16/2024: there was no case delay reported.The case was completed without an arthrex product and completed by freehand.No adverse effects on the patient.Additional information was received on 08/01/2024: the drill bit part number is ar-8920dc cannulated drill bit, 3.5 mm.It could not be removed from the sleeve of the ar-8963-21 lag drill guide and is still inside the drill lag.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged, lag drill guide, 3.5 mm / 2.5 mm, ar-8963-21, was received for investigation.The visual investigation noted that the outer sleeve, the end cap, the inner sleeve, and the spring components were broken off (per drawing c1628).Functional testing could not be performed due to the damage of the device.The most likely cause for the reported failure can be attributed to excessive user-applied mechanical forces.

• Brand Name: LAG DRILL GUIDE, 3.5 MM / 2.5 MM
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 19905052
• Report Number: 1220246-2024-07016
• Device Sequence Number: 12978596
• Product Code: MDM
• UDI-Device Identifier: 00888867364349
• UDI-Public: 00888867364349
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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: LAG DRILL GUIDE, 3.5 MM / 2.5 MM
• Device Catalogue Number: AR-8963-21
• Device Lot Number: 1392101
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown