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

Catalog Number DYNJ41395C

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that approximately on (b)(6) 2018, the blade broke off of the handle and fell into the patient's knee during a total knee arthroplasty requiring visual retrieval by surgeon.It was reported that the product was inspected prior to use and the issue was not identified at that time.General anesthesia was used and there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.No additional information was provided related to the reported incident.The condition of the device is not known.A root cause has not been determined.No additional information is available.A sample has not been returned for evaluation however, due to the reported incident and in an abundance of caution, 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 that the blade broke off of the handle and fell into the patient's knee.

• Type of Device: EXTREMITY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093 ; 2249311514
• MDR Report Key: 7300055
• MDR Text Key: 101064912
• Report Number: 1423395-2018-00006
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10888277937222
• UDI-Public: 10888277937222
• 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: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: DYNJ41395C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention