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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
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 that the device broke.There was no harm for patient, operator or third party reported.No further information received.Update 30-aug-2022.It was confirmed that the device broke during a surgery on the (b)(6) 2022.All broken parts were retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.One ar-10010, 3.4 mm probe hook tip, w/5.0 mm markings, batch number 75629, was received for investigation.Visual evaluation confirms the hooked tip broke off and it was not returned.The critical dimension on the tip cannot be verified because of the missing part.The light blue probe handle color is faded.Visual evaluation signs of wear.The cause remains undetermined.However, the observed condition is most likely the result of levering the device against hard bone or other instrumentation during use.

• 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: 15401862
• Report Number: 1220246-2022-05478
• Device Sequence Number: 14997186
• 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): 11/29/2022

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: 75629
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown