MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; EXTREMITY I

Model Number	DYNJS0821
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient was undergoing a first metatarsal osteotomy on the left foot.The facility contact stated that during the procedure the #15 knife blade broke into 2 pieces.Once piece on the knife handle and one piece in the patients left foot.Both pieces were completely retrieved.An x-ray was performed on the patients left foot and no blade piece was noted in the patient's foot.The patient is reportedly doing fine.The device was discarded in the sharps container and is no longer available to be returned for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this is a reportable incident.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the patient was undergoing a first metatarsal osteotomy on the left foot and the blade broke into 2 pieces requiring manual removal of the blade from the surgical site.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: EXTREMITY I
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12169636
• Report Number: 1423395-2021-00035
• Device Sequence Number: 924928
• Product Code: OJH
• UDI-Device Identifier: 10080196986651
• UDI-Public: 10080196986651
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/14/2021

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: DYNJS0821
• Device Catalogue Number: DYNJS0821
• Device Lot Number: 21CBG349
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 07/14/2021
• 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: 38 YR