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

Model Number	SUPRAPATELLAR INSERTION GUIDE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems-06039695 that a 1255-300 suprapatellar insertion guide and a 1239-100 locking knob insertion guide had an issue during a tibial nail procedure on (b)(6) 2023.The patient was a 15 yo with hard bone, they reamed 2mm larger than the selected nail size, which was a size 9 nail.Upon insertion of the nail, the jig broke but wasn¿t noticed until trying to rotate the nail, and then it fully separated when trying to back slap the nail to gain compression of the fracture.The surgeon was able to get the piece of jig out of the patient.He had to do perfect circles proximally.This is the 2nd time this situation has happened.This occurred during use with no patient harm.Additional information has been requested.
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
Additional information: b.5 event updated.G.3 follow-up information received.H.6 updated.The complaint is confirmed.One unpackaged 1255-300 tibial insertion guide, extended batch 212469, was received for investigation.The visual evaluation revealed that the received insertion guide was detached.It was noted that part 1239-100 locking bolt is still attached to the returned device.It was observed damaged along the returned 1255-300 as the laser marks faded.The reported condition is most likely caused by overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging.
Event or Problem Description
On 1/15/2024, the sales representative provided the following information via email: the procedure was completed by the surgeon manually inserting the screws proximally instead of through the jig.There was no case delay reported, and the procedure was completed successfully.The first incident had previously been reported to arthrex.

• 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: 17996270
• Report Number: 1220246-2023-08338
• Device Sequence Number: 17812684
• Product Code: HSB
• UDI-Device Identifier: 00848665039153
• UDI-Public: 00848665039153
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070444
• 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): 02/23/2024

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: 212469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown