MAUDE Adverse Event Report: ARTHREX, INC. Ø3.2MM PIN GUIDE, LOCKING; INTRAMED FIXATN ROD AND ACCESS

Model Number	Ø3.2MM PIN GUIDE, LOCKING
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
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 07/16/2024, it was reported by a sales representative via sems-(b)(4) that a 1268-100 targeting arm was misaligned and repeatedly missed the lag screw.And a 0312-200 pin guide was getting stuck in the sleeve spring.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.One unpackaged 0312-200 3.2mm pin guide lot number: 211587 was received for evaluation.Visual evaluation noted wear and tear with scratches observed throughout the surface of the device.The most likely cause for this failure can be attributed to wear and tear incurred from repeated use.Functional testing was performed by assembling the 0312-200 3.2mm pin guide with a 0617-300 lag screw sheath lot number: p12888.It was noted that the 0312-200 3.2mm pin guide was able to lock and detach as intended, no problem was noted with the release spring.

• Brand Name: Ø3.2MM PIN GUIDE, LOCKING
• 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: jared engle ; 8009337001
• MDR Report Key: 19961219
• Report Number: 1220246-2024-07137
• Device Sequence Number: 17912314
• Product Code: HSB
• UDI-Device Identifier: 00848665010664
• UDI-Public: 00848665010664
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/27/2024

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: Ø3.2MM PIN GUIDE, LOCKING
• Device Catalogue Number: 0312-200
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/27/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown