MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CRANI PACK-LF

Catalog Number	DYNJ0415291L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6), the item broke during the surgery while it's being applied to the ski (scalp).Nothing changed in how it was used before.This occurred after surgical incision while it's being applied and hooked onto to the scalp.The item broke in two pieces, so the surgeon did a methodical sweep and an x-ray was taken.Radiation exposure (x-ray) was needed to ensure that all broken pieces were retrieved.There were interruptions during the procedure that hindered the complete exposure of the surgical incision, resulting in some frustrations among the team but the procedure was completed.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 (b)(6), the item broke during the surgery while it's being applied to the ski (scalp).

• Common Device Name: CRANI PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 21508399
• Report Number: 1423395-2025-00022
• Device Sequence Number: 7974754
• Product Code: OJH
• UDI-Device Identifier: 10195327677596
• UDI-Public: 10195327677596
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/03/2025

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 Expiration Date: 12/31/2025
• Device Catalogue Number: DYNJ0415291L
• Device Lot Number: 24HLB106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 70 YR
• Patient Sex: Male