MAUDE Adverse Event Report: STRYKER GMBH HOOK PLATE VARIAX CLAVICLE 6 HOLE / 12MM / RIGHT; PLATE, FIXATION, BONE

Catalog Number 628516S

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device evaluated by mfr: device remains implanted.

Event Description

It was reported that variax clavicle surgery was performed on (b)(6) 2019.When the surgeon tried to lock the locking screw to the second hole from the distal end of the plate, it did not lock.The surgeon decided to leave the screw in a state that is not locked to the plate.The procedure was otherwise completed successfully with no surgical delay or adverse consequences reported.

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 (such as the x-rays from different angles) as well as the affected device must be available in order to determine the root cause of the complaint event.Based on the complaint history, some potential root causes can be assumed, but 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 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: ¿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.

Event Description

It was reported that variax clavicle surgery was performed on 5/7/2019.When the surgeon tried to lock the locking screw to the second hole from the distal end of the plate, it did not lock.The surgeon decided to leave the screw in a state that is not locked to the plate.The procedure was otherwise completed successfully with no surgical delay or adverse consequences reported.

• Brand Name: HOOK PLATE VARIAX CLAVICLE 6 HOLE / 12MM / RIGHT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8668134
• MDR Text Key: 148271704
• Report Number: 0008031020-2019-00521
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327085525
• UDI-Public: 07613327085525
• Combination Product (y/n): N
• PMA/PMN Number: K140259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 628516S
• Device Lot Number: L15278
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR