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

Model Number	PIVOTPOST REPLACEMENT
Medical Device Problem Code	Break (1069)
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
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 or Problem 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.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Complaint allegation is 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 being broken off.Visual evaluation noted that the rotation lever was broken off.The most likely cause for the reported failure can be attributed to misuse/mishandling due to the damage to the device.Refer to investigation photos.
Additional Manufacturer Narrative
**udi related data quality updates only** updated information in d4 for correct udi (b)(4).

• Brand Name: PIVOTPOST REPLACEMENT
• Common Device Name: 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
• Report Number: 1220246-2023-08140
• Device Sequence Number: 20714254
• Product Code: BWN
• UDI-Device Identifier: 00888867095205
• UDI-Public: (01)00888867095205(10)012144
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup,Followup
• Report Date (Section B): 07/25/2024

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: PIVOTPOST REPLACEMENT
• Device Catalogue Number: AR-1560-02
• Device Lot Number: 012144
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: Not provided; Not provided; 07/25/2024
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 07/24/2024; 07/25/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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