MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 8MM X 40MM CROSS-SCREW (TITANIUM); PIN, FIXATION, THREADED

Catalog Number 234-500-140

Device Problems Break (1069); Difficult to Remove (1528); Sticking (1597)

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

Event Date 09/03/2015

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that the surgeon was putting in a titanium cross screw for his femoral fixation.The screw went over the step pin and got stuck.The step pin was not able to come out for 20 min.It broke trying to remove it.All pieces were retrieved from the patient.There was no adverse consequences and no medical intervention reported.The surgery was completed successfully.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Visual inspection: broken insertion pin is stuck inside the cross screw, but no physical damage observed throughout the cross screw.Also, insertion pin deformation observed, and distal and proximal breakage to insertion pin observed as well.The proximal piece and the distal piece of insertion pin were not received.The probable root cause for the reported failure involving this device could be due to excessive force applied by user to device.

Event Description

It was reported that the surgeon was putting in a titanium cross screw for his femoral fixation.The screw went over the step pin and got stuck.The step pin was not able to come out for 20 min.It broke trying to remove it.All pieces were retrieved from the patient.There was no adverse consequences and no medical intervention reported.The surgery was completed successfully.

• Brand Name: 8MM X 40MM CROSS-SCREW (TITANIUM)
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: kimberly lynch ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 5112611
• MDR Text Key: 27207668
• Report Number: 0002936485-2015-00863
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K011319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 234-500-140
• Device Lot Number: 14233AG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1