MAUDE Adverse Event Report: MEDLINE RENEWAL Medline; ASHA 4250-01 AMBIENT ARTHROW SUPER TUR

Model Number	ASHA42500RH
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer on (b)(6) 2023 the ablation wand was flaking off inside the patient during a surgical procedure.
Additional Manufacturer Narrative
According to the customer on (b)(6) 2023 the ablation wand was flaking off inside the patient during a surgical procedure.Per the facility the incident occurred "about 45 minutes" into the device being used.Per the facility "the surgeon took the burr and removed the flakes and finished the case with the same device".No additional information is available at this time.The sample was returned for evaluation and the reported issue could not be confirmed, therefore, a definitive root cause could not be determined at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline
• Common Device Name: ASHA 4250-01 AMBIENT ARTHROW SUPER TUR
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16525033
• Report Number: 3032391-2023-00002
• Device Sequence Number: 6458428
• Product Code: NUJ
• UDI-Device Identifier: 10888277669895
• UDI-Public: 10888277669895
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ASHA42500RH
• Device Catalogue Number: ASHA42500RH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown