MAUDE Adverse Event Report: ARTHREX, INC. Ø3.2MM PIN GUIDE, LOCKING; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	Ø3.2MM PIN GUIDE, LOCKING
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 it was reported by a sales representative via sems that an 0616-000 obturator, pin guide, end cap has disconnected from the shaft.And an 0312-200 pin guide spring attachment clamp that connects the clamp to the lag screw sheath has broken and can no longer be locked together.This was discovered during a procedure on (b)(6)2022.
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.(1) unpackaged 0312-200 was received for investigation.Visual inspection revealed that the protruding tip of the spring-loaded clamp is broken.No other issues were found.Without additional information, the probable cause remains undetermined.The failure could have been the result of impact with another device, or mishandling of the device.

• Brand Name: Ø3.2MM PIN GUIDE, LOCKING
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: vik bajnath ; 8009337001
• MDR Report Key: 13621242
• Report Number: 1220246-2022-04538
• Device Sequence Number: 17528575
• Product Code: HSB
• UDI-Device Identifier: 00848665010664
• UDI-Public: 00848665010664
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K132005
• 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): 08/09/2022

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: 02/09/2022
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown