MAUDE Adverse Event Report: SYNTHES, INC. CRADLE CAP HOLDER FROM TITANIUM RIB KIT; PROSTHESIS RIB KIT

Lot Number 7282227

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

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

Event Date 07/27/2016

Event Type  malfunction  

Event Description

During a titanium rib procedure a cradle cap holder was used to remove a cradle cap.The instrument has 2 small prongs which broke off.One is stuck in the cradle.The second has been removed from the patient.Replacement of right vertical expandable prosthetic titanium rib prosthesis, reseating the superior cradle of the right vertical expandable prosthetic titanium rib prosthesis, expansion of bilateral vertical expandable prosthetic titanium rib prosthesis.

• Brand Name: CRADLE CAP HOLDER FROM TITANIUM RIB KIT
• Type of Device: PROSTHESIS RIB KIT
• Manufacturer (Section D): SYNTHES, INC.; west chester PA 19380
• MDR Report Key: 6202149
• MDR Text Key: 63276612
• Report Number: MW5066885
• Device Sequence Number: 1
• Product Code: MDI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 7282227
• Was Device Available for Evaluation?: Yes
• 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 Age: 6 YR
• Patient Weight: 18