MAUDE Adverse Event Report: ARTHREX, INC. SUPRAPATELLAR INSERTION GUIDE; INTRAMED FIXATN ROD AND ACCESS

Model Number	SUPRAPATELLAR INSERTION GUIDE
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
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
On 11/16/2023, it was reported by a sales representative via sems-06403211 that a 1255-300 tibial insertion guides metal jig where the nail connects came loose (sounds like the spot wields broke), and the nail would spin and not line up with the jig.The 1239-100 insertion guide was stripped and would not come out of the 1255-300.This occurred during a case with no effect on the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint is confirmed.One unpackaged 1255-300 tibial insertion guide was received for evaluation.The 1255-300 was received with an 1239-100 locking knob attached and stuck to it.Upon visual inspection, it was noted that the part of the 1255-300 tibial insertion guide where the nail attaches had scratches.The most likely cause for this failure can be attributed to misuse due to mishandling the device.Functional testing was attempted to be performed, however, the part of the 1255-300 tibial insertion guide where the nail attaches was loose and easily removable as the welding had broken, and functional testing could not be performed.The most likely cause for this failure can be attributed to wear and tear incurred over repeated usage.

• Brand Name: SUPRAPATELLAR INSERTION GUIDE
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• 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: emily shafer ; 8009337001
• MDR Report Key: 18340877
• Report Number: 1220246-2023-09454
• Device Sequence Number: 12461790
• Product Code: HSB
• UDI-Device Identifier: 00848665039153
• UDI-Public: 00848665039153
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/03/2024

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: SUPRAPATELLAR INSERTION GUIDE
• Device Catalogue Number: 1255-300
• Device Lot Number: 212471
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown