MAUDE Adverse Event Report: ARTHREX, INC. OSTETOME, ANGLED UP, 12MM; ARTHROSCOPIC ACCESSORIES

Model Number	OSTETOME, ANGLED UP, 12MM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 9/5/2023, it was reported by a sales representative via sems-06022369 that an ar-8970-13 osteotome, angled up 12 mm was damaged.The item came from a set and was discovered during a case.There were no adverse effects to the patient.This occurred during use in an unspecified procedure with no patient harm.Additional information has been requested.
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 ar-8970-13, batch 041439 was received for investigation.The visual evaluation revealed that the received device's blade tip had nicks and was damaged.The most likely cause(s) of this type of event include applying excessive forces through leveraging/prying the device.

• Brand Name: OSTETOME, ANGLED UP, 12MM
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• 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: 17863859
• Report Number: 1220246-2023-08059
• Device Sequence Number: 5704770
• Product Code: NBH
• UDI-Device Identifier: 00888867133846
• UDI-Public: 00888867133846
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/01/2023

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: OSTETOME, ANGLED UP, 12MM
• Device Catalogue Number: AR-8970-13
• Device Lot Number: 041439
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 12/01/2023
• 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