MAUDE Adverse Event Report: STRYKER STRYKER CORTEX SCREW 3.5 X 60/70MM; PLATE, FIXATION, BONE

Device Problems Material Fragmentation (1261); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/05/2017

Event Type  malfunction  

Event Description

Stryker cortical screw: 3.5 x 60 or 70 mm, distal third left broken in patient's pelvis.First head broke off, then doctor tried to remove screw, but he was only able to remove part of the shaft and the rest is left in patient.

• Brand Name: STRYKER CORTEX SCREW 3.5 X 60/70MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER; 750 trade centre way; ste. 200; portage MI 49002
• MDR Report Key: 7003630
• MDR Text Key: 91121455
• Report Number: 7003630
• Device Sequence Number: 1
• Product Code: HRS
• 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: 10/26/2017,11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2017
• 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: 18 YR