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

Catalog Number	DYNJ38747F
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported by the facility that while that surgeon was attempting to release the rotator cuff during rotator cuff surgery by using the blade, the blade broke into 2 pieces.When the surgeon used the grasper to retrieve the 2 pieces from the surgical site, the blade broke into 4 pieces.The surgeon was able to retrieve 3 of the 4 pieces however the 4th piece remains retained in the soft tissue of the patients shoulder.The length of the case was slightly increased in order to retrieve the broken pieces of the blade however there was no impact to the patient's stability as a result of the extension.The procedure was completed without further incident.No additional information is available.The device/retrieved pieces were not returned for evaluation.Due to the reported incident, 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 surgical blade broke into four pieces and was manually retrieved from the patient however one piece remained retained in the patients shoulder.

• Common Device Name: SHOULDER PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10967783
• Report Number: 1423395-2020-00043
• Device Sequence Number: 13698740
• Product Code: OJH
• UDI-Device Identifier: 10193489284263
• UDI-Public: 10193489284263
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2020

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: Health Professional
• Device Catalogue Number: DYNJ38747F
• Device Lot Number: 20KBB529
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2020
• 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: 68 YR
• Patient Weight: 104