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

Model Number ELEVATOR, 15 DEGREE SHOULDER TISSUE

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2023

Event Type  malfunction  

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 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.

• Brand Name: ELEVATOR, 15 DEGREE SHOULDER TISSUE
• Type of Device: 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
• MDR Text Key: 325509967
• Report Number: 1220246-2023-08168
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867012561
• UDI-Public: 00888867012561
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/14/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1