MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; MAJOR EXTREMITY

Catalog Number	DYNJ83705A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on 12/5/23 "while setting up supplies for case long black hair was found under towels on top of drape inside sterile pack".Per the facility "patient was awakened and taken to recovery room while instruments were re-processed, then brought back to the operating room for case".Per the facility the patient required additional anesthesia as they required a reversal and re-induction.No additional information is available.The sample was requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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
According to the facility on 12/5/23 "while setting up supplies for case long black hair was found under towels on top of drape inside sterile pack".

• Common Device Name: MAJOR EXTREMITY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18412328
• Report Number: 1423395-2023-00080
• Device Sequence Number: 18334726
• Product Code: OJH
• UDI-Device Identifier: 10195327420178
• UDI-Public: 10195327420178
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/28/2023

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?: No
• Device Catalogue Number: DYNJ83705A
• Device Lot Number: 23GME064
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown