MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SHOULDER PACK

Catalog Number	DYNJ30112G
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that during a shoulder arthroscopy, the blade broke into the surgical site.The reported blade broke into three (3) separate pieces and the surgeon visually removed the pieces from the surgical site with the use of the arthroscopic camera and a grasper.The patient required additional anesthesia during this retrieval process and the overall procedure was reportedly prolonged for an additional thirty (30) minutes.A new blade was reportedly obtained and the procedure was completed with no further incident.There was no reported effect to patient stability.The actual blade involved in the incident was returned to the manufacturer for evaluation and the reported product issue was confirmed.However, a root cause could not be determined.No information related to the handle used in this incident was provided.Due to the need for medical intervention to retrieve the broken pieces and the prolonged exposure to anesthesia, 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 during a shoulder arthroscopy, the blade broke into the surgical site.

• Common Device Name: SHOULDER PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7439816
• Report Number: 1423395-2018-00016
• Device Sequence Number: 13766165
• Product Code: OJH
• UDI-Device Identifier: 10889942589777
• UDI-Public: 10889942589777
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2018

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: Physician
• Device Catalogue Number: DYNJ30112G
• Device Lot Number: 18AB9528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/18/2018
• 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: 75 YR
• Patient Weight: 87