MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; SHOULDER PACK

Catalog Number	DYNJ83122C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on 9/11, "we were making a port incision for a arthroscopic rotator cuff repair and the blade broke in half.The broken tip of the blade was in the shoulder.Dr (b)(6) retrieved the broken off blade tip using the camera and another port site.There was no serious injury and no impact to the patient or the procedure.The procedure was completed".A sample is not available for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.
Event or Problem Description
According to the facility on 9/11, "we were making a port incision for a arthroscopic rotator cuff repair and the blade broke in half.".

• Common Device Name: SHOULDER PACK
• 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: 20417486
• Report Number: 1423395-2024-00489
• Device Sequence Number: 18207255
• Product Code: LRO
• UDI-Device Identifier: 40195327616381
• UDI-Public: 40195327616381
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/10/2024

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: DYNJ83122C
• Device Lot Number: 24FBH236
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 10/10/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Female