MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK DURA HOOKS; 6MM NEURO ELASTIC RETRACTORS

Model Number REF 382800

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/30/2018

Event Type  Injury  

Event Description

Surgeon used device to hold back skin flap / muscle during cranial surgery, and was unaware portion of hook broke off during surgery and was retained in pt's temporal muscle.Required surgical incision for removal.Piece of hook that broke off and was retained in pt is in the possession of hosp risk mgmt.

• Brand Name: WECK DURA HOOKS
• Type of Device: 6MM NEURO ELASTIC RETRACTORS
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC 27709
• MDR Report Key: 8206305
• MDR Text Key: 131831916
• Report Number: 8206305
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2020
• Device Model Number: REF 382800
• Device Catalogue Number: UKN
• Device Lot Number: UKN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/16/2018
• Event Location: Hospital
• 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): Required Intervention
• Patient Age: 15 YR
• Patient Weight: 58