MAUDE Adverse Event Report: ARTHREX, INC. PEEKPOWER HTO PLATE BONE SPREADER; ORTHOPEDIC MANUAL SURG INSTR

Model Number	PEEKPOWER HTO PLATE BONE SPREADER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/10/2025, a sales representative reported via sems-(b)(4) that an ar-1340t peekpower hto plate bone spreaders tip broke.This occurred during a case.The fragment was retrieved, and nothing was left inside the patient.They replaced the device with a similar product to complete the case successfully.The item will be returned to arthrex for evaluation.There was no patient harm or adverse event.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged, ar-1340t, plate bone spreader, batch 1068642104, was received for investigation.Visual inspection noted that the handle was broken.Functional testing was not performed due to the damage of the device.The most likely cause of the reported failure is wear and tear.Due to continuous mechanical forces applied to it, the device will inevitably sustain damage over time.Refer to the investigation photos.Complaint allegation is confirmed.

• Brand Name: PEEKPOWER HTO PLATE BONE SPREADER
• Common Device Name: 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: jared engle ; 8009337001
• MDR Report Key: 21942538
• Report Number: 1220246-2025-01827
• Device Sequence Number: 8799748
• Product Code: LXH
• UDI-Device Identifier: 00888867012295
• UDI-Public: 00888867012295
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 08/06/2025

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: PEEKPOWER HTO PLATE BONE SPREADER
• Device Catalogue Number: AR-1340T
• Device Lot Number: 1068642104
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown