MAUDE Adverse Event Report: ENDOTEC INC. ENDOTEC WHALETAIL RETRACTOR

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/17/2021

Event Type  Injury  

Event Description

Pt undergoing left total knee replacement and the stainless steel whaletail retractor tip broke off in the surgical site.The tip was not able to be retrieved and after consultation with another orthopedic surgeon it was decided to leave it in place rather than risk damaging the nerves that were in the area.Fda safety report id# (b)(4).

• Brand Name: ENDOTEC WHALETAIL RETRACTOR
• Type of Device: RETRACTOR
• Manufacturer (Section D): ENDOTEC INC. ; 1501 n. harbor blvd. ; ste 209; fullerton CA 92835
• MDR Report Key: 12238670
• MDR Text Key: 264064923
• Report Number: MW5102794
• Device Sequence Number: 1
• Product Code: GAD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/23/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 167