MAUDE Adverse Event Report: ARTHREX, INC. PNCH, LG, 2.75 W/FLUSHPORT; MANUAL INSTR, GENERAL SURGICAL

Model Number	PNCH, LG, 2.75 W/FLUSHPORT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
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
It was reported the plastic plain bearing of the sliding shaft, on the jaw side, has come loose.There was no harm for patient, operator or third party reported.There was no case involvement reported.No further information received.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.One unpackaged, ar-11200f, batch 14094129, was received for investigation.Visual evaluation noted no problems with the exterior of the device.Functional testing was performed with a test sheet; it was noted that the cutter was able to cut through the test sheet and works as intended.Additionally, it was also found that the handle was slightly loose.

• Brand Name: PNCH, LG, 2.75 W/FLUSHPORT
• Common Device Name: MANUAL INSTR, GENERAL 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: 19378164
• Report Number: 1220246-2024-03685
• Device Sequence Number: 18024724
• Product Code: MDM
• UDI-Device Identifier: 00888867270855
• UDI-Public: 00888867270855
• 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): 09/16/2024

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: PNCH, LG, 2.75 W/FLUSHPORT
• Device Catalogue Number: AR-11200F
• Device Lot Number: 14094129
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 08/31/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown