MAUDE Adverse Event Report: ARTHREX, INC. SHORT 2.9 PUSHLOCK SHAVERDRILL; POWERED SURG ORTHOPEDIC INSTR

Model Number	SHORT 2.9 PUSHLOCK SHAVERDRILL
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems that an 2.9 mm pushlock shaverdrill¿, ar-2923dsr, left plastic shavings inside of two different shaver hand controls, ar-8330h (sn: (b)(6)) and ar-8332h (sn: (b)(6)).Both shavers apparently were grinding the attachments, and now have plastic shavings inside, preventing normal use.No adverse event or patient harm due to the outcome of this event.Please see pictures attached.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.Two boxes containing three sealed blisters packaged each ar-2923dsr, batch number 15047598 were received for evaluation.The visual evaluation did not find issues.Two devices were randomly selected and tested using the testing console and the handpiece at various speeds.It was observed that the hub, which was colored purple, began to disintegrate, resulting in plastic shavings.Furthermore, a burning odor was noticed during the test.The observed and reported failure is most likely due to an internal manufacturing issue.

• Brand Name: SHORT 2.9 PUSHLOCK SHAVERDRILL
• Common Device Name: POWERED SURG ORTHOPEDIC 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: 17304767
• Report Number: 1220246-2023-07119
• Device Sequence Number: 7184875
• Product Code: HWE
• UDI-Device Identifier: 00888867239456
• UDI-Public: 00888867239456
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/26/2025

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: SHORT 2.9 PUSHLOCK SHAVERDRILL
• Device Catalogue Number: AR-2923DSR
• Device Lot Number: 15047598
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• 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