MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L46MM; PLATE, FIXATION, BONE

Model Number	657346S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.
Event or Problem Description
It was reported: the plate and screw did not lock well.I redid the drill a few times, but in the end it didn't lock.
Event or Problem Description
It was reported: the plate and screw did not lock well.I redid the drill a few times, but in the end it didn't lock.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the reported event.However, based on the device history review, some possible root causes are, but are not limited to: - the locking part of the screw thread could have been stripped during the usage of the screw, preventing the locking mechanism to function properly.This could have lead to the creation of a slope in the thread preventing the screw to fully engage in the plate, and so, it prevented the locking mechanism to work.- this is a single use device, however it cannot be excluded that the damages to the thread occurred in a previous usage of this device.Note, as stated in the ifu: ¿warnings ¿ single use devices cannot be reused, as they are not designed to perform as intended after the first usage.Changes in mechanical, physical or chemical characteristics introduced under conditions of repeated use, cleaning and re-sterilization may compromise the integrity of the design and/or materials leading to diminished safety, performance and/or compliance with relevant specifications.Please refer to the device label to identify single or multiple use and/or cleaning and re-sterilization release.¿ - note that the insertion angle of the locking screw should be a cone with 30° angle.Any excesses in the angulation might lead to the non function of the locking mechanism and even the damage of the thread of the screw.Note, as stated in the operative technique guide: ¿smartlock locking technology the polyaxial locking technology works by using two different grades of titanium.Locking screws are made of titanium alloy (ti6a14v) which is stronger than the pure titanium plate.When a screw is driven into a plate hole, the locking threads on the underside of the screw head engage the circular ¿lip¿ in the hole.This technology allows the surgeon to aim and lock the screw within a 30° cone.¿ 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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L46MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10139615
• Report Number: 0008031020-2020-01584
• Device Sequence Number: 11298353
• Product Code: HRS
• UDI-Device Identifier: 07613327087321
• UDI-Public: 07613327087321
• Combination Product (Y/N): N
• PMA/510(K) Number: K132502
• 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): 07/20/2020

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 Expiration Date: 01/31/2023
• Device Model Number: 657346S
• Device Catalogue Number: 657346S
• Device Lot Number: L58496
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 07/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR