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

Model Number	DYNJS0110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
• Common Device Name: SURE SET SURGICAL SET-UP
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11316420
• Report Number: 1423395-2021-00010
• Device Sequence Number: 4078871
• Product Code: LRO
• UDI-Device Identifier: 10080196971275
• UDI-Public: 10080196971275
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYNJS0110
• Device Catalogue Number: DYNJS0110
• Device Lot Number: 20EBG161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/11/2021
• 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: 59 YR