MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; SURE SET SURGICAL SET-UP

Model Number DYNJS0110

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that the blade was being used on tissue for a toe amputation procedure and during use the blade broke at the connection to the handle resulting in the blade falling into the surgical site.The surgeon was able to retrieve the blade with forceps, switch the blade out with a new device and continue with the procedure without delay.The sample was discarded and is not available to be returned for evaluation.There was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported that the blade was being used on tissue for a toe amputation procedure and during use the blade broke at the connection to the handle resulting in the blade falling into the surgical site.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: SURE SET SURGICAL SET-UP
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 11316420
• MDR Text Key: 232154913
• Report Number: 1423395-2021-00010
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10080196971275
• UDI-Public: 10080196971275
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJS0110
• Device Catalogue Number: DYNJS0110
• Device Lot Number: 20EBG161
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR