MAUDE Adverse Event Report: ORTHOFIX INC. ORTHOFIX; DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 03/30/2018

Event Type  malfunction  

Event Description

Screwdriver tip broke while implanting screw.

• Brand Name: ORTHOFIX
• Type of Device: DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
• Manufacturer (Section D): ORTHOFIX INC.; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 7435690
• MDR Text Key: 105686643
• Report Number: 7435690
• Device Sequence Number: 1
• Product Code: JDO
• 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: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Other Device ID Number: TRY-IN 11 00-N
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1