MAUDE Adverse Event Report: ARTHREX, INC. SD DISP. KIT FOR SHORT 2.9 PUSHLOCK, HB; POWERED SURG ORTHOPEDIC INSTR

Model Number	SD DISP. KIT FOR SHORT 2.9 PUSHLOCK, HB
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 10/11/2024, a sales representative reported via (b)(4) that an ar-2923dtsk shaverdrill¿ disposables kit for short 2.9 mm pushlock® anchor had an issue.This shaver drill was used in conjunction with the reusable drill guide and left a considerable amount of metal debris in the joint space.They spent a decent amount of time cleaning all the metal debris out of the joint.No adverse effects on the patient were reported, and cleaned the debris out of the joint.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: h6 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.The most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the device during use.

• Brand Name: SD DISP. KIT FOR SHORT 2.9 PUSHLOCK, HB
• 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: jared engle ; 8009337001
• MDR Report Key: 20557715
• Report Number: 1220246-2024-08303
• Device Sequence Number: 11538955
• Product Code: HWE
• UDI-Device Identifier: 00888867276635
• UDI-Public: (01)00888867276635(11)231114(17)281031(10)15167149
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 07/08/2025

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: SD DISP. KIT FOR SHORT 2.9 PUSHLOCK, HB
• Device Catalogue Number: AR-2923DTSK
• Device Lot Number: 15167149
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2023
• 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