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

Catalog Number DYNJ0151255A

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2019

Event Type  malfunction  

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 Description

It was reported that during a surgical procedure, the surgical blade broke and pieces fell into the surgical site.

• Type of Device: SURGICAL BLADE IN KNEE ARTHROSCOPY MIOSH PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 8577317
• MDR Text Key: 145771761
• Report Number: 1423395-2019-00014
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10889942245611
• UDI-Public: 10889942245611
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 118