MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; LHC IN MACS UPPER EXTREMITY PACK

Model Number	DYNJ24793L
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the lhc detached and fell into the surgical site during an unspecified procedure.Despite multiple good faith attempts the reporting facility was unable or unwilling to provide additional patient, product, or procedural information related to the incident.No adverse patient impact was originally reported.Twenty-five (25) lhc samples were received for investigation.No physical damage or visible defect to the shaft or opening of the lhc were noted.During further inspection, the shaft height and the inner and outer diameter of the opening of the lhc were measured and found to be within the lhc's range tolerance.The lhc appeared to be within specification.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the light handle cover (lhc) detached and fell into the surgical site.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: LHC IN MACS UPPER EXTREMITY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12462518
• Report Number: 1423395-2021-00041
• Device Sequence Number: 4986301
• Product Code: OJH
• UDI-Device Identifier: 10889942389490
• UDI-Public: 10889942389490
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2021

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 Model Number: DYNJ24793L
• Device Catalogue Number: DYNJ24793L
• Device Lot Number: 21GBF360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 09/13/2021
• 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: Other