MAUDE Adverse Event Report: ARTHREX, INC. 125° RADIOLUCENT TARGETING ARM; INTRAMED FIXATN ROD AND ACCESS

Model Number	125° RADIOLUCENT TARGETING ARM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/28/2023, it was reported by a sales representative via sems-06016727 that a 1267-000 targeting arms distal hole on the jig was not lining up on the short nail.This occurred during a hip orif, where the drill was skiving anteriorly.There was no patient effect 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
The complaint is confirmed.One unpacked 1267-000 125° radiolucent targeting arm batch 130079 was received for evaluation.Visual inspection noted that the impactor protector silver ring was missing.Laser marks are faded.Damage was observed all around the device.A functional test with a trochanteric nail found the jig misaligned.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• Brand Name: 125° RADIOLUCENT TARGETING ARM
• 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: 17810308
• Report Number: 1220246-2023-07970
• Device Sequence Number: 17928743
• Product Code: LXH
• UDI-Device Identifier: 00848665010879
• UDI-Public: 00848665010879
• 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): 11/06/2024

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: 125° RADIOLUCENT TARGETING ARM
• Device Catalogue Number: 1267-000
• Device Lot Number: 130079
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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