MAUDE Adverse Event Report: SYMMETRY SURGICAL RHOTON SHARP MICRO NERVE HOOK

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

Patient Problem Foreign Body In Patient (2687)

Event Date 08/14/2017

Event Type  malfunction  

Event Description

While performing surgery, piece of motion sharp micro nerve hook broke off in pt.Unable to locate prior to end of case and closure of wound.

• Brand Name: RHOTON SHARP MICRO NERVE HOOK
• Type of Device: RHOTON SHARP MICRO NERVE HOOK
• Manufacturer (Section D): SYMMETRY SURGICAL; antioch TN 37013
• MDR Report Key: 6809624
• MDR Text Key: 83367715
• Report Number: MW5071709
• Device Sequence Number: 1
• Product Code: GDG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Age: 35 YR
• Patient Weight: 78