MAUDE Adverse Event Report: STRYKER TRAUMA SELZACH CANCELLOUS SCREW Ø4.0X40MM; PLATE, FIXATION, BONE

Catalog Number 604040

Device Problems Sticking (1597); Material Deformation (2976)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/24/2015

Event Type  malfunction  

Event Description

The screw thread was deformed when it was used for removing the insert from the tibial tray after tka.The screw was stuck in the tibial tray.The thread was deformed.The event occurred during surgery.

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.

• Brand Name: CANCELLOUS SCREW Ø4.0X40MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4706356
• MDR Text Key: 5666101
• Report Number: 0008031020-2015-00163
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K972323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 604040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other