MAUDE Adverse Event Report: ARTHREX, INC. OUTRIGGER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	OUTRIGGER
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/4/2022, it was reported by a sales representative via email that an in6000 outrigger tip broke.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
Complaint confirmed.One unpackaged in6000 serial/batch number (b)(6) was received for investigation.Visual evaluation of the device outrigger found that the hub attachment tube had the tip broken off.No fragments were returned for analysis.The root cause of the reported failure mode is undetermined.However, the most probable cause is applying excessive mechanical forces upon insertion.

• Brand Name: OUTRIGGER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 15657304
• Report Number: 1220246-2022-05641
• Device Sequence Number: 6377181
• Product Code: LXH
• UDI-Device Identifier: 00816988011743
• UDI-Public: 00816988011743
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 03/13/2023

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: OUTRIGGER
• Device Catalogue Number: IN6000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 03/13/2023
• 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