MAUDE Adverse Event Report: ARTHREX, INC. PROBE, HOOK 3.4MM TIP W/5MM MARKINGS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	PROBE, HOOK 3.4MM TIP W/5MM MARKINGS
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic cartilage smoothing at the knee joint the distal end of the device broke off.The tip of the device could not be retrieved out of the patient.No information provided by the customer.25-nov-2021 update: further information was provided that the surgery was finished successfully with a new device with the same part number.
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.
Additional Manufacturer Narrative
Complaint confirmed, the hooked tip broke off.The cause of the broken tip is undetermined, however a likely cause is user-applied mechanical forces.Additionally, the device is dented and handle discoloration due to wear and tear.

• Brand Name: PROBE, HOOK 3.4MM TIP W/5MM MARKINGS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 12983419
• Report Number: 1220246-2021-04080
• Device Sequence Number: 14510343
• Product Code: LXH
• UDI-Device Identifier: 00888867002364
• UDI-Public: 00888867002364
• 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): 12/29/2021

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: PROBE, HOOK 3.4MM TIP W/5MM MARKINGS
• Device Catalogue Number: AR-10010
• Device Lot Number: 76247
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown