MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG LOCKING SCREW, T10, 3.5X24MM; PLATE, FIXATION, BONE

Catalog Number 40-35624

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

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.Kaiser has kept the plate.

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 and 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: LOCKING SCREW, T10, 3.5X24MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6575808
• MDR Text Key: 75459401
• Report Number: 0008010177-2017-00108
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063875
• 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: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 40-35624
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2017
• 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): Required Intervention
• Patient Age: 57 YR