MAUDE Adverse Event Report: ARTHREX, INC. METATARSAL REAMER, 22MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	METATARSAL REAMER, 22MM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Insufficient Information (4580)
Date of Event	01/19/2022
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 a ar-8944mr-22 reamer grabbed onto the bone and ripped it apart so instead of shaving down to a cone shape it just broke.This occurred during a case, 45 additional minutes were added to try fixing all the broken bones.No additional information provided.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.Per dfu-0023-eo - i.Cautions1.Users of this device are encouraged to contact their arthrex representatives if, in their professional judgment, they require a more comprehensive surgical technique or more information.Arthrex provides detailed surgical techniques in print, video, and electronic formats.The arthrex website also provides detailed surgical technique information and demonstrations.The most likely cause of the reported failure is user error, such as misaligned insertion or excessive force during use.

• Brand Name: METATARSAL REAMER, 22MM
• Common Device Name: 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: vik bajnath ; 8009337001
• MDR Report Key: 16303173
• Report Number: 1220246-2023-06231
• Device Sequence Number: 12499410
• Product Code: LXH
• UDI-Device Identifier: 00888867053175
• UDI-Public: 00888867053175
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 08/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: METATARSAL REAMER, 22MM
• Device Catalogue Number: AR-8944MR-22
• Device Lot Number: 1392222
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown