MAUDE Adverse Event Report: INTEGRA RHOTON HOOK 90 BLUNT

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

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

Event Date 08/19/2015

Event Type  Injury  

Event Description

A micro dissector tip broke off in side the surgical site.Doctor was able to locate and remove the broken tip.The tip and the instrument were immediately removed from the sterile field.

• Brand Name: RHOTON HOOK 90 BLUNT
• Type of Device: RHOTON HOOK 90 BLUNT
• Manufacturer (Section D): INTEGRA
• MDR Report Key: 5057990
• MDR Text Key: 25109238
• Report Number: MW5055958
• Device Sequence Number: 2
• Product Code: GZX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/31/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 84