MAUDE Adverse Event Report: ARTHREX, INC. SFT TISSUE PRTCTR, 2.4MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SFT TISSUE PRTCTR, 2.4MM
Medical Device Problem Codes	Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/05/2025, a sales representative via (b)(4) reported that an ar-8770-06 soft tissue protector had a drill bit lodged and stuck inside the protector device.They tried to remove the drill bit, but it stuck inside.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation was confirmed.One unpackaged ar-8770-06 soft tissue protector, 2.4 mm batch/lot number 04511846 was received for evaluation.The device was received with a (ar-8943-42 batch 1392313) drill stuck inside the cannulation guide.The drill is damaged and bent in different places of the shaft.Upon visual evaluation, heavy signs of wear were observed on the device.The laser marks are faded, with discoloration spots all around.Functional testing was not performed as the device was received damaged.The most likely reason for the reported failure is user error, due to misuse causing the drill to get stuck and bent inside the instrument.

• Brand Name: SFT TISSUE PRTCTR, 2.4MM
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 21412844
• Report Number: 1220246-2025-00556
• Device Sequence Number: 8316877
• Product Code: LXH
• UDI-Device Identifier: 00888867263758
• UDI-Public: (01)00888867263758(11)181129(10)04511846
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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: SFT TISSUE PRTCTR, 2.4MM
• Device Catalogue Number: AR-8770-06
• Device Lot Number: 04511846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2018
• 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