MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SURGICAL BLADE IN KNEE ARTHROSCOPY MIOSH PACK-LF

Catalog Number	DYNJ0151255A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a left knee arthroscopy with medial menisectomy procedure, the surgical blade broke and pieces fell into the surgical site.The surgical blade pieces were required to be retrieved from the surgical site by the surgeon.The procedure lasted longer than originally planned due to retrieval of the surgical blade pieces.There was no reported need for the administration of additional anesthesia.No impact or adverse effect to the patient, the patient's stability, or the patient's plan of care was reported.A sample was returned to the manufacturer for evaluation.Visual inspection confirmed that the surgical blade broke on the edge opposite of the blade.Although the breakage appeared as though it was possibly caused by excessive force, a definitive root cause could not be determined.Due to the need for medical intervention to retrieve the broken surgical blade 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 during a surgical procedure, the surgical blade broke and pieces fell into the surgical site.

• Common Device Name: SURGICAL BLADE IN KNEE ARTHROSCOPY MIOSH PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8577317
• Report Number: 1423395-2019-00014
• Device Sequence Number: 14210776
• Product Code: OJH
• UDI-Device Identifier: 10889942245611
• UDI-Public: 10889942245611
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/03/2019

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 Catalogue Number: DYNJ0151255A
• Device Lot Number: 18LDA653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/03/2019
• 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: 54 YR
• Patient Weight: 118