MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW,T8 FULL THREAD, 2.7MM/L16MM; SCREW, FIXATION, BONE

Model Number	656316
Medical Device Problem Codes	Material Fragmentation (1261); Difficult to Insert (1316)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The surgeon was using a variax2 dr implant kit together with an ordinary instrument kit.When inserting a locking screw, he experienced that the screw would not engage in the plate and some metal chips were detected.They kept the plate in place and used other screws in the plate.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the microscope inspection of the threads of the locking mechanism under the head of the screw showed that the thread is damaged.The material of the threads is gnawed, which causes the screw not to lock on the plate anymore.Some possible root causes that could have caused the deformation of the device are, but are not limited to: -the use of a large force during the insertion of the device.The use of a large insertion angle than the acceptable value for the position of the screw on the plate.The damage of the screw during storage, transportation or handling of the device.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to be user related.The failure was caused by the damage of the screw during insertion.If any further information is provided, the complaint report will be.
Event or Problem Description
The surgeon was using a variax2 dr implant kit together with an ordinary instrument kit.When inserting a locking screw, he experienced that the screw would not engage in the plate and some metal chips were detected.They kept the plate in place and used other screws in the plate.

• Brand Name: LOCKING SCREW,T8 FULL THREAD, 2.7MM/L16MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9775873
• Report Number: 0008031020-2020-00535
• Device Sequence Number: 16716504
• Product Code: HWC
• UDI-Device Identifier: 07613327068689
• UDI-Public: 07613327068689
• Combination Product (Y/N): N
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 656316
• Device Catalogue Number: 656316
• Device Lot Number: 1000260215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1