MAUDE Adverse Event Report: ARTHREX, INC. ELEVATOR, 15 DEGREE SHOULDER TISSUE; MANUAL INSTR, GENERAL SURGICAL

Model Number	ELEVATOR, 15 DEGREE SHOULDER TISSUE
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
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 9/14/2023, it was reported by a sales representative via (b)(4) that an ar-1342-15 shoulder tissue elevator, 15° had an issue.The instrument was bent during surgery but did not break, and the surgery continued with a new instrument.This occurred during use in an unspecified procedure with no patient harm.Additional information has been requested.On 9/18/2023, the sales representative provided the following information via email: this occurred during a labral repair and debridement procedure - hwr metal anchors from the glenoid.This was a revision surgery, but no arthrex products were being removed.The initial first surgery date was not provided.Another ar-1342-15 shoulder tissue elevator, 15° with an unknown lot number, was used to complete the procedure successfully.The bone quality of the patient was not provided.No pictures were taken.There was no adverse effect to the patient reported and no case delay.
Additional Manufacturer Narrative
Complaint allegation was not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause(s) for the reported failure can be a user error due to improper bone preparation, misaligned insertion, and/or prying/levering the device during insertion.

• Brand Name: ELEVATOR, 15 DEGREE SHOULDER TISSUE
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: emily shafer ; 8009337001
• MDR Report Key: 17921712
• Report Number: 1220246-2023-08168
• Device Sequence Number: 6795399
• Product Code: MDM
• UDI-Device Identifier: 00888867012561
• UDI-Public: 00888867012561
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 10/24/2024

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: ELEVATOR, 15 DEGREE SHOULDER TISSUE
• Device Catalogue Number: AR-1342-15
• Device Lot Number: 01091503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown