MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SURGICAL BLADE IN DBD-ARTHRO SHOULDER BEACH CHAIR

Catalog Number DYNJ58138B

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/05/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported by the reporting facility that 2 surgical blades detached from the handle.One blade got stuck in the patient and "was safely removed from the patient".The reporting facility does not wish to disclose any further information at this time.No additional information is available.No sample has been returned to the manufacturer for evaluation, therefore a root cause was unable to be determined at this time.Due to the reported nature of this incident, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported the surgical blade detached from the handle.

• Type of Device: SURGICAL BLADE IN DBD-ARTHRO SHOULDER BEACH CHAIR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, il ; 9311514
• MDR Report Key: 9802557
• MDR Text Key: 190769037
• Report Number: 1423395-2020-00006
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ58138B
• Device Lot Number: 19VBE660
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention