MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; #11 SURGICAL BLADE IN ARTHROSCOPY PACK

Catalog Number DYNJ906040A

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that during a knee arthroscopy procedure, the #11 blade (taken from custom sterile tray), on a knife handle, was handed to the surgeon for the initial incision.Upon removing the scalpel from the knee, it was reportedly noted that the blade was no longer attached to the knife handle and blade was left behind inside the patient's knee.It was denied that excessive force was applied to or against the blade.The surgeon reportedly utilized an arthroscope to visualize the blade pieces and the blade pieces were successfully removed using graspers.No further tests or treatment was required.No injury to the patient or to the surgeon was reported.It was reported that the patient was under general anesthesia and the procedure was lengthened to allow time for blade retrieval.Due to medical intervention required to retrieve the broken blade from the patient's knee, this medwatch is being filed.The sample has been discarded and is not available to be returned for evaluation.A definitive root cause for the reported issue could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that arthroscope and graspers were used to successfully retrieve a surgical blade that broke off into patient's knee.

• Type of Device: #11 SURGICAL BLADE IN ARTHROSCOPY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 9192278
• MDR Text Key: 170109387
• Report Number: 1423395-2019-00037
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ906040A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention