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

Model Number METATARSAL 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 signs of having been used heavily.Review of this complaint confirmed the event summary code selection.The complaint is confirmed.The probable cause of the event could not be determined from the information available; however, a most likely cause is wear and tear.The investigation did not change the potential harm(s) identified.Complaint trending for this event will be performed per (b)(4).

• Brand Name: METATARSAL REAMER, 18MM
• Type of Device: 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: 17662215
• MDR Text Key: 322408631
• Report Number: 1220246-2023-07705
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867053151
• UDI-Public: 00888867053151
• 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: 11/02/2023

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: METATARSAL REAMER, 18MM
• Device Catalogue Number: AR-8944MR-18
• Device Lot Number: 032018
• 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: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1