MAUDE Adverse Event Report: ARTHREX, INC. POWERPICK, 45 DEG; BURR,SURGICAL

Model Number	POWERPICK, 45 DEG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
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
It was reported that drill tip and the shaft broke during a demonstration.It was noticed before the surgery.There was no harm for patient, operator or third party.There was no case involvement reported.No further information received.Update dw 18-jul-2024: further information was received that the reported event occurred during a hip-arthroscopy.Update dw 30-jul-2024: the surgery was finished successfully with a new device with the same part number and all broken fragments were retrieved out of the patient.
Additional Manufacturer Narrative
Complaint allegation was confirmed.One unpackaged ar-8150pp-45 batch 15213373 was received for evaluation.Upon visual inspection, no broken parts were observed on the device.However, the power pick's inner shaft does not retract when the lever is actuated.A scratch was noted on the curve/angle of the outer shaft, which may indicate that the device came into contact with another instrument.Functional testing with the console and the handpiece found that the inner shaft doesn't move because of the break.The most likely cause(s) of the reported failure is user error, such as prying/leveraging the device or using it without irrigation.Dfu-0215-eor0_fmt_en.F.Precautions.6.Do not allow the rotating portion of any device to touch any metallic object, such as a cannula or arthroscope, during use.Damage to both devices is likely.Damage to the device can range from a slight distortion or dulling of the blade/burr edge to actual fracture of the tip in vivo.If such contact does occur, inspect the tip.If there are cracks, fractures or dulling, or if there is any other reason to suspect a blade is damaged, replace it immediately.7.Excessive "side-loading" on the device during use does not improve cutting performance and in extreme cases will cause irreversible damage to the device.

• Brand Name: POWERPICK, 45 DEG
• Common Device Name: BURR,SURGICAL
• 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: 19992616
• Report Number: 1220246-2024-07177
• Device Sequence Number: 20940702
• Product Code: GFA
• UDI-Device Identifier: 00888867042919
• UDI-Public: 00888867042919
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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: POWERPICK, 45 DEG
• Device Catalogue Number: AR-8150PP-45
• Device Lot Number: 15213373
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2024
• 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