MAUDE Adverse Event Report: STRYKER GMBH POLYAXIAL LOCKING PLATE VARIAX2 NAVICULAR-CUNEIFORM, RIGHT, SHORT (T10); PLATE, FIXATION, BONE

Catalog Number 626752S

Device Problems Difficult To Position (1467); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

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

Event Date 09/14/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

We were fusing the navicular-cuneiform joint.Initially placed a 4.0 mm screw through the joint then use the nc plate over the top.We placed the proximal screws on navicular then went to use the compression rap with a 3.5 mm non locking screw.As we were screwing it in the head of the screw fell completely through the plate.This forced us to remove the construct & start over again, weakening the compression across the arthrodesis site.We placed the plate on again and then closed the case.In post op the doctor noticed unusual movement in the foot and realized our construct had fallen apart.We went in again for surgery the next day using a 5.0 inner frag, bigger plate & external fixation on top.

• Brand Name: POLYAXIAL LOCKING PLATE VARIAX2 NAVICULAR-CUNEIFORM, RIGHT, SHORT (T10)
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5990390
• MDR Text Key: 56036230
• Report Number: 0008031020-2016-00493
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140376
• 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: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 626752S
• Device Lot Number: F19946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2016
• Initial Date FDA Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR