MAUDE Adverse Event Report: ARTHREX, INC. PIVOTPOST REPLACEMENT; OPERATING ROOM TABLE ACCESS

Model Number PIVOTPOST REPLACEMENT

Device Problem Break (1069)

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

Event Date 09/13/2023

Event Type  malfunction  

Manufacturer Narrative

Complaint confirmed.One unpackaged ar-1560-02 serial/batch number (b)(6) was received for investigation.Functional testing was not conducted due to the damage to the instrument's rotation level was broken off.Visual evaluation noted that the rotation lever was broken off.The reported condition is most likely caused by overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging.

Event Description

On 9/13/2023, it was reported by a sales representative via sems-06030096 that an ar-1560-02 pivotpost replacement snapped off during a case.The clip broke off to where it is unusable, as it will not pivot at all.This was discovered during an unspecified procedure, with no patient harm.

• Brand Name: PIVOTPOST REPLACEMENT
• Type of Device: OPERATING ROOM TABLE ACCESS
• 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: 17914730
• MDR Text Key: 325417373
• Report Number: 1220246-2023-08140
• Device Sequence Number: 1
• Product Code: BWN
• UDI-Device Identifier: 00888867095205
• UDI-Public: 00888867095205
• 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: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PIVOTPOST REPLACEMENT
• Device Catalogue Number: AR-1560-02
• Device Lot Number: 012144
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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