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

Model Number OSTETOME, ANGLED UP, 12MM

Device Problem Defective Device (2588)

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

Event Date 09/05/2023

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 325691525
• Report Number: 1220246-2023-08059
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867133846
• UDI-Public: 00888867133846
• 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,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/05/2023
• Initial Date FDA Received: 10/03/2023
• Supplement Dates Manufacturer Received: 09/05/2023
• Supplement Dates FDA Received: 12/01/2023
• 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