MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline Industries, Inc.; EAR CDS

Model Number	DYNJ900356Q
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility during the middle of a procedure, 'the blade broke off in the middle ear and was retrieved with an instrument'.Per the facility when the issue occurred, the procedure needed to be stopped to collect all pieces and assess for tissue damage.According to the facility all pieces were accounted for and a new blade was opened to complete the procedure with no serious injury noted.The sample was returned for evaluation but a root cause could not be determined at this time.No additional information is available at this time.Due to the reported incident and 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.
Event or Problem Description
According to the facility during the middle of a procedure, 'the blade broke off in the middle ear and was retrieved with an instrument'.

• Brand Name: Medline Industries, Inc.
• Common Device Name: EAR CDS
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15498375
• Report Number: 1423395-2022-00032
• Device Sequence Number: 5970061
• Product Code: OGR
• UDI-Device Identifier: 10195327098001
• UDI-Public: 10195327098001
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/27/2022

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: DYNJ900356Q
• Device Catalogue Number: DYNJ900356Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown