MAUDE Adverse Event Report: SYNTHES SPIKE PUSHER

Model Number 390.71

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

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

Event Date 12/15/2014

Event Type  Injury  

Event Description

Patient underwent insertion of a trochanteric fixation nail for fractured hip.Ball spike pushers were used to help reduce the fracture.Upon removal of the spike pusher, the clip dislodged in the patient's fascia.Final fluoroscopy done in the operating room was negative for retained clip per physician.Routine post operative films of the hip obtained in pacu showed the clip from the ball spiker pusher was retained.Removal of clip was done on (b)(6) 2014.

• Brand Name: SPIKE PUSHER
• Type of Device: SPIKE PUSHER
• Manufacturer (Section D): SYNTHES
• MDR Report Key: 4375356
• MDR Text Key: 5237886
• Report Number: MW5039841
• Device Sequence Number: 1
• Product Code: HXO
• 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: 12/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 390.71
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR