MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4MM SELF DRILLING SCREWS; IMPLANT

Catalog Number 12-01532S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2015

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.

Event Description

The surgeon at the clinic reported to the company representative that while correctly using the grip (screwdriver at 90 degrees perpendicular), the surgeon lost a quickflap screw during the operation.Basically, the screw would not retain well with the screwdriver blade.For another screw, it was impossible to screw because the head print disappeared.There was no impact for the patient.

Manufacturer Narrative

The complained screws have not been returned.Therefore it is not possible to confirm the reported event.During the investigation process the information was provided that the event happened in a test situation (therefore it was new practice / first application).The surgeon¿s habit is to use the closure kit of a competitor¿s medical device company which has a different performance.According to the accompanying instruction for use of the stryker quikflap device set it is essential to ensure, that the screwdriver/screw head connection is exactly aligned in the vertical direction and axial pres-sure is put on the connection; otherwise there will be an increased risk of mechanical damage to implant (plates, burr hole covers and screws) and screwdriver blade or loss of the screw during application.Based on statistical evaluation there are no indications for any systematic design, material or manufacturing related issue.The complaint is added to the complaint trend.

Event Description

The surgeon at the clinic reported to the company representative that while correctly using the grip (screwdriver at 90 degrees perpendicular), the surgeon lost a quickflap screw during the operation.Basically, the screw would not retain well with the screwdriver blade.For another screw, it was impossible to screw because the head print disappeared.There was no impact for the patient.

• Brand Name: QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4MM SELF DRILLING SCREWS
• Type of Device: IMPLANT
• 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: jonathan schell ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 5144807
• MDR Text Key: 28484742
• Report Number: 0008010177-2015-00254
• Device Sequence Number: 1
• Product Code: GWO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K120352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12-01532S
• Device Lot Number: 1000170706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2015
• 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