MAUDE Adverse Event Report: SYNTHES INC. CABLE 1.0MMX750XX W/CRIMP; GUIDEWIRE

Model Number 298.800.01S

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/13/2016

Event Type  malfunction  

Event Description

Patient was undergoing open treatment of the left closed patellar fracture with partial patellectomy and open reduction, internal fixation as treatment for a closed left comminuted stellate patellar fracture.Upon positioning of the guidewire (part of the synthes cannulated screw system), the tip of the guidewire broke.The surgeon attempted multiple times to retrieve the tip but was unsuccessful.At that time, it was decided to leave the tip in the bone as further attempts to retrieve it would have caused additional injury to the patella.There was no injury to the patient nor did this product issue cause a prolonged length of stay.Because there were 2 of these guidewires used during this procedure, there are 2 lot numbers but we are unable to determine which lot # is associated with the wire that broke.Both lot numbers are: p214134 and p226664.Is the product compounded: no.Is the product over-the-counter: no.

• Brand Name: CABLE 1.0MMX750XX W/CRIMP
• Type of Device: GUIDEWIRE
• Manufacturer (Section D): SYNTHES INC.; west chester PA 19380
• MDR Report Key: 6185405
• MDR Text Key: 62863890
• Report Number: MW5066750
• Device Sequence Number: 1
• Product Code: JDQ
• 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: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 298.800.01S
• Device Lot Number: 9214134
• Was Device Available for Evaluation?: No
• 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: 36 YR
• Patient Weight: 105