MAUDE Adverse Event Report: ARTHREX, INC. OBTURATOR, PIN GUIDE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	OBTURATOR, PIN GUIDE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/07/2022
Type of Reportable Event	Malfunction
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.
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 complaint is confirmed.(2) unpackaged 0616-000 were received for investigation.Visual inspection revealed that one of the devices had no issues.The other device was noted as having the knob detached from the pin shaft, with a broken weld.The pin shaft was tested against a grade a surface plate and was noted as being slightly bent.Since the pin shaft is bent, a probable cause can be attributed to the application of mechanical forces against the device via leveraging/prying.

• Brand Name: OBTURATOR, PIN GUIDE
• 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: 13621205
• Report Number: 1220246-2022-04537
• Device Sequence Number: 5543205
• Product Code: HSB
• UDI-Device Identifier: 00848665002478
• UDI-Public: 00848665002478
• 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: OBTURATOR, PIN GUIDE
• Device Catalogue Number: 0616-000
• 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