MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM; PLATE, FIXATION, BONE

Catalog Number	657312
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2018
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
Primary procedure, right clavicle.It was reported that in implanting the variax2 core 3.5 locking screws into the clavicular plate, the screws would not lock - they kept spinning when they should have locked.Rep obtained locking screws from a variax 1 ankle solution set, which locked as expected.The plate is implanted and the reported screws are available for return.Rep reported that surgeon was following the surgical technique throughout the procedure.There was a surgical delay of 5 minutes.
Event or Problem Description
Primary procedure, right clavicle.It was reported that in implanting the variax2 core 3.5 locking screws into the clavicular plate, the screws would not lock - they kept spinning when they should have locked.Rep obtained locking screws from a variax 1 ankle solution set, which locked as expected.The plate is implanted and the reported screws are available for return.Rep reported that surgeon was following the surgical technique throughout the procedure.There was a surgical delay of 5 minutes.
Additional Manufacturer Narrative
Please note correction to conclusion: the reported event should indicate locking screw variax2 t10, full thread, 3.5mm/l12mm not locking screw variax2 t10, full thread, 3.5mm/l10mm.
Additional Manufacturer Narrative
The reported event that locking screw variax2 t10, full thread, 3.5mm / l10mm was alleged of 'no locking effect' could be confirmed.Based on the investigation, the root cause was attributed to a user related issue.The locking part of the screw thread was most likely stripped during the usage of the screw, preventing the locking mechanism to function properly.The device inspection revealed that there is a part of the thread missing in the threaded locking part of the screw.This 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.¿ [original statement(s)] additionally, 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 : ¿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.¿ [original statement(s)] the device inspection revealed the following: both screws return present a high deformation of their threads, which explains the impossibility of the user to lock them to the plate.Since the screws were checked during manufacturing and that no deviation was found, it can be concluded that the deformation of the threads happened during use.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.
Event or Problem Description
Primary procedure, right clavicle.It was reported that in implanting the variax2 core 3.5 locking screws into the clavicular plate, the screws would not lock - they kept spinning when they should have locked.Rep obtained locking screws from a variax 1 ankle solution set, which locked as expected.The plate is implanted and the reported screws are available for return.Rep reported that surgeon was following the surgical technique throughout the procedure.There was a surgical delay of 5 minutes.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7891487
• Report Number: 0008031020-2018-00615
• Device Sequence Number: 1484649
• Product Code: HRS
• UDI-Device Identifier: 07613327086812
• UDI-Public: 07613327086812
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 11/16/2018

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: 657312
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 10/18/2018; 11/16/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 11/12/2018; 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 14 YR