MAUDE Adverse Event Report: ARTHREX, INC. PHALANGEAL REAMER, 18MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	PHALANGEAL REAMER, 18MM
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
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 submitted.
Event or Problem Description
On (b)(6)2023, it was reported by a sales representative via sems that an ar-8944mr-18 metatarsal reamer and an ar-8944pr-18 phalangeal reamer were getting dull.This was discovered during an unspecified procedure, with no patient harm.
Additional Manufacturer Narrative
The complaint was confirmed.One unpackaged ar-8944pr-18, serial/batch number (b)(6), was received for investigation.Upon visual evaluation, it was noted signs of wear and tear.The sharp edges at the tip have nicks and are dull.Corrosion was noted close to the cutting edges.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.Devices with cutting functions or sharp points become dull with continuous use.This condition does not indicate a device defect.This condition indicates normal wear.Dull devices may require replacement if they no longer perform as designed.Inspection prior to use should include verifying the cutting ability and sharpness of these points and edges.

• Brand Name: PHALANGEAL REAMER, 18MM
• 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: emily shafer ; 8009337001
• MDR Report Key: 17576606
• Report Number: 1220246-2023-07562
• Device Sequence Number: 20924826
• Product Code: LXH
• UDI-Device Identifier: 00888867053212
• UDI-Public: 00888867053212
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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: PHALANGEAL REAMER, 18MM
• Device Catalogue Number: AR-8944PR-18
• Device Lot Number: 032032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• 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
• Patient Sex: Unknown