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

Model Number PHALANGEAL REAMER, 18MM

Device Problem Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2023

Event Type  malfunction  

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 Description

On (b)(6) 2023, it was reported by a sales representative via sems the following: an ar-8944mr-18 metatarsal reamer (batch#032018) is getting dull.An ar-8944mr-20 metatarsal reamer (batch#031543) is getting dull.An ar-8944mr-22 metatarsal reamer (batch#041429) is getting dull.An ar-8944pr-18 phalangeal reamer (batch#031841) is getting dull.An ar-8944pr-20 phalangeal reamer (batch#032010) is getting dull.An ar-8944pr-22 phalangeal reamer (batch #041415) is getting dull.This was discovered during an unspecified procedure, with no adverse event or patient harm.

Manufacturer Narrative

Complaint is confirmed.Upon visual evaluation, it was noted that the edges of the reamer are worn, showing nicks and dents and signs of having been used heavily.The directions for use (dfu) warns against using dull devices.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.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• Brand Name: PHALANGEAL REAMER, 18MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 17662246
• MDR Text Key: 322409262
• Report Number: 1220246-2023-07708
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867053212
• UDI-Public: 00888867053212
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

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
• Device Operator: Health Professional
• Device Model Number: PHALANGEAL REAMER, 18MM
• Device Catalogue Number: AR-8944PR-18
• Device Lot Number: 031841
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 08/02/2023
• Supplement Dates FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1