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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On 3/13/2023, it was reported by a medwatch letter via email that an ar-1249 nitinol guide pin for bio-interference screws broke in the patient's tibia during a left knee arthroscopic assisted anterior cruciate ligament reconstruction with patellar tendon autograft and lateral meniscus repair procedure on (b)(6) 2022.The broken guide pin was discovered during a postoperative scan.A revision surgery took place to remove the broken fragment.No further information was reported.
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
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to misaligned insertion and/or prying/leveraging the device during use.

• 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: 16645657
• Report Number: 1220246-2023-06503
• Device Sequence Number: 14964621
• Product Code: MDM
• UDI-Device Identifier: 00888867006164
• UDI-Public: 00888867006164
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown