MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC SYNTHES K-WIRE (KIRSCHNER WIRE); PIN, FIXATION

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

Patient Problem Foreign Body In Patient (2687)

Event Date 11/20/2015

Event Type  malfunction  

Event Description

During procedure to stabilize ankle fracture, a 10-hole left plate was used- while placing the k-wire for stability, it broke off in the bone and the orthopedic surgeon opted to leave it in place as an implant.

• Brand Name: SYNTHES K-WIRE (KIRSCHNER WIRE)
• Type of Device: PIN, FIXATION
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC; 700 orthopaedic drive; warsaw, IN 46582
• MDR Report Key: 5317715
• MDR Text Key: 34089812
• Report Number: 5317715
• Device Sequence Number: 1
• Product Code: JDW
• 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: Other
• Type of Report: Initial
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR