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

Catalog Number DYNJ38747F

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/01/2020

Event Type  Injury  

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 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.

• Type of Device: SHOULDER PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 10967783
• MDR Text Key: 220193152
• Report Number: 1423395-2020-00043
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10193489284263
• UDI-Public: 10193489284263
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ38747F
• Device Lot Number: 20KBB529
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 104