MAUDE Adverse Event Report: ARTHREX, INC. NIT G-PIN. BIO-INTERF SCRW 1.1MM; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	NIT G-PIN. BIO-INTERF SCRW 1.1MM
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
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 during a knee surgery the pins broke at the "laser marking" end.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update 10-feb-2023: it was confirmed that the device broke inside the patient and all fragments were removed from the patient.
Additional Manufacturer Narrative
Complaint is not confirmed.Dimensional testing found that the overall length of 15.18 ±.03 inches per drawing c2796 of both devices was between the tolerances (15.19 - 15.20 inches).Upon visual evaluation, it was noted that each one of the two devices has an entire circumference at their two distal ends.No problem found.

• Brand Name: NIT G-PIN. BIO-INTERF SCRW 1.1MM
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: 16427334
• Report Number: 1220246-2023-06326
• Device Sequence Number: 2557120
• Product Code: MDM
• UDI-Device Identifier: 10888867006161
• UDI-Public: 10888867006161
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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: NIT G-PIN. BIO-INTERF SCRW 1.1MM
• Device Catalogue Number: AR-1249
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown