MAUDE Adverse Event Report: ARTHREX, INC. G-WIRE W/TRCR TIP, THDD, 062"X9.25"; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	G-WIRE W/TRCR TIP, THDD, 062"X9.25"
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 1/12/2023, it was reported by a facility representative via medwatch email that an ar-8750kt guide wire with trocar tip broke off in the patient's right ankle.The pin likely bent while it was being inserted and therefore when it was removed, the tip broke off.The surgeon attempted to remove the broken piece but was unsuccessful after several hours.Surgeon determined that if the joint was to be reopened, it would have potentially caused more harm by damaging the repair that was already completed.Per surgeon, after 10 weeks post operative, to let the repair to heal, a revision surgery can take place to remove the pin.No additional information has been provided at this time.
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 allegation is not confirmed.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.Per dfu-0023-eo rev 4 i.Cautions- 2.To avoid damaging the instruments, do not impact or subject to blunt force any instruments that are designed to be turned or screwed in.When two devices are intended to be threaded together, ensure that they are fully engaged prior to use.6.Flexion of the joint with the instrument in position in the joint may result in bending or breakage of the instrument.7.Do not overstress the device or use device to pry tissue.The most likely cause for the reported failure can be attributed to misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: G-WIRE W/TRCR TIP, THDD, 062"X9.25"
• 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: 16263941
• Report Number: 1220246-2023-06200
• Device Sequence Number: 4881066
• Product Code: LXH
• UDI-Device Identifier: 00888867263642
• UDI-Public: 00888867263642
• 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): 08/30/2024

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: G-WIRE W/TRCR TIP, THDD, 062"X9.25"
• Device Catalogue Number: AR-8750KT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 08/30/2024
• 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
• Patient Sex: Unknown