MAUDE Adverse Event Report: MEDLINE INDUSTRIES; SHOULDER SCOPE PACK

Catalog Number	DYNJ55854
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that during a left shoulder arthroscopy procedure the blade broke into three pieces.The facility reported that the blade was inspected by the surgical tech prior to being placed onto the knife handle however during the portal incision for the arthroscopy the blade broke into pieces.All of the pieces were retrieved from the patient at the time of the procedure but the retrieval of the blade resulted in the procedure being extended.The procedure was prolonged however there was no report of any adverse patient consequence or effect on the patient's stability as a result of the incident.There was no serious injury, follow-up medical care or medical intervention required.Per the facility, the blade was disposed of in a sharps container and is not available to be returned for evaluation.A root cause cannot be determined.Due to the need for surgical intervention and in an abundance of caution, this medwatch is being filed.
Event or Problem Description
During a left shoulder arthroscopy procedure the blade broke into three pieces.

• Common Device Name: SHOULDER SCOPE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES; three lakes drive; northfield IL 60093
• MDR Report Key: 6897293
• Report Number: 1423395-2017-00023
• Device Sequence Number: 13759064
• Product Code: LRO
• UDI-Device Identifier: 10889942583485
• UDI-Public: 10889942583485
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/26/2017

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
• Operator of Device: Physician
• Device Catalogue Number: DYNJ55854
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 09/27/2017
• 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: 37 YR
• Patient Weight: 84