MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; SURGICAL BLADE IN DBD-ARTHROSCOPY PACK

Model Number	DYNJ53895A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the surgical blade broke into three (3) pieces during a knee arthroscopy procedure.Reportedly, the broken pieces fell into the surgical site.Using x-ray fluoroscopy, all broken pieces were located and retrieved from the surgical site without further reported incident.The reporting facility indicated that the patient was discharged home after the procedure and no adverse patient impact, additional medical intervention, or follow-up care related to the incident was reported.A sample was returned for evaluation and the surgical blade was confirmed to be broken into three (3) pieces.A root cause was unable to be determined.Due to the reported need for medical intervention to retrieve the broken surgical pieces from the surgical site, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the surgical blade broke during a procedure.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: SURGICAL BLADE IN DBD-ARTHROSCOPY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12128158
• Report Number: 1423395-2021-00034
• Device Sequence Number: 4370617
• Product Code: OJH
• UDI-Device Identifier: 10889942945856
• UDI-Public: 10889942945856
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2021

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: DYNJ53895A
• Device Catalogue Number: DYNJ53895A
• Device Lot Number: 20LBA947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 126