MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SURGICAL BLADE IN HAND AND FOOT PACK-LF

Catalog Number	DYNJ0151441C
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a heel spur procedure, the surgical blade broke and fell the broken piece fell into the surgical wound.At the time of the incident, the surgical blade was reportedly being used to "cut tissue deep in the wound." the broken surgical blade piece was retrieved from the surgical site via a hemostat and with assistance from a c-arm x-ray machine.No further incident was reported to the manufacturer.The patient reportedly received additional anesthesia to complete the procedure.No impact or adverse effect to the patient was reported to the manufacturer.A sample was returned to the manufacturer for evaluation and the reported surgical blade issue was confirmed.A definitive root cause could not be established.Due to the need for medical intervention, this medwatch is being filed.If additional relevant information becomes available this report will be reopened and reevaluated.
Event or Problem Description
It was reported that the surgical blade broke during use.The broken surgical blade piece fell into the surgical wound.

• Common Device Name: SURGICAL BLADE IN HAND AND FOOT PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8907344
• Report Number: 1423395-2019-00029
• Device Sequence Number: 2001259
• Product Code: OJH
• UDI-Device Identifier: 10889942155637
• UDI-Public: 10889942155637
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2019

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: DYNJ0151441C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 08/19/2019
• 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