MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW,T8 FULL THREAD, 2.7MM/L12MM; SCREW, FIXATION, BONE

Catalog Number	656312
Medical Device Problem Codes	Material Deformation (2976); Scratched Material (3020)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that, during a primary procedure on a right radius, the locking screw would not lock into the plate.When seated, the screw kept spinning.Another screw was used to successfully complete the surgery with an approximate one minute delay.No adverse consequences were reported.
Event or Problem Description
It was reported that, during a primary procedure on a right radius, the locking screw would not lock into the plate.When seated, the screw kept spinning.Another screw was used to successfully complete the surgery with an approximate one minute delay.No adverse consequences were reported.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by the damage of the screw during insertion.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.When the screw is inserted in any hole in the variax plate, the screw does not lock.The screw "turns" infinitely.The event can thus be confirmed.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 as a reminder, the ifu clearly states: ''ensure that you are familiar with the intended uses, indications/ contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.Please remember that product systems may be subject to alterations that affect the compatibility of the implant with other implants or with instruments.For your information, avail yourself of the training courses and publications offered (e.G.Operative techniques).¿ avoid surface damage of implants.¿ discard all damaged or mishandled implants." 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.If any further information is provided, the investigation report will be updated.

• Brand Name: LOCKING SCREW,T8 FULL THREAD, 2.7MM/L12MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8668538
• Report Number: 0008031020-2019-00522
• Device Sequence Number: 16772025
• Product Code: HWC
• UDI-Device Identifier: 07613327068665
• UDI-Public: 07613327068665
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

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 Catalogue Number: 656312
• Device Lot Number: 1000341399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2019
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1