MAUDE Adverse Event Report: ARTHREX, INC. 130° RADIOLUCENT TARGETING ARM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	130° RADIOLUCENT TARGETING ARM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 6/25/2024, a sales representative via sems(b)(4) reported that a 1268-100 radiolucent targeting arm, 130 degree troch nail had an issue.The inside screw that accepts the 0826-000 impactor pad came out of the actual jig itself and is attached to the impactor pad and will not come loose.The patient was not harmed.A photo is provided.This was discovered during a procedure, with no reported patient harm.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged 1268-100 radiolucent targeting arm batch number: 210929 was received for investigation.The 1268-100 radiolucent targeting arm was received with an 0826-000 impactor pad batch number: 211082 attached to it.Visual inspection of the returned devices noted that the 0826-000 impactor pad was stuck to the grommet of the 1268-100 radiolucent targeting arm and could not be detached.Functional testing was unable to be performed due to the devices being unable to be separated.The most likely cause for the reported failure can be attributed to user error due to excessive mechanical forces being applied to the impactor pad.

• Brand Name: 130° RADIOLUCENT TARGETING ARM
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: jared engle ; 8009337001
• MDR Report Key: 19770839
• Report Number: 1220246-2024-06805
• Device Sequence Number: 20983660
• Product Code: HSB
• UDI-Device Identifier: 00848665028645
• UDI-Public: 00848665028645
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K021008
• 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): 09/23/2024

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: 130° RADIOLUCENT TARGETING ARM
• Device Catalogue Number: 1268-100
• Device Lot Number: 210929
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown