MAUDE Adverse Event Report: STRYKER GMBH SLIM STRAIGHT PLATE, 3 HOLES (T8) VARIAX2 FOOT; PLATE, FIXATION, BONE

Catalog Number 626963

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ambulation Difficulties (2544); Implant Pain (4561)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.

Event Description

As reported: "lisfranc total dislocation.(b)(6) 2020 1st surgery k-wires were used to stabilize the foot.(b)(6) 2020 2nd surgery was performed orif where plate and 6 screws were used along with 2 k-wires.I have received physical therapy, use orthotics.Multiple x-rays there is pain through the foot and pain in side where plate is unable to move first 2 toes without using my hands.Times where i am unable to walk or put pressure on left foot".

Manufacturer Narrative

The reported event could be confirmed, through the additional patient medical reports that were shared.A device inspection was not possible since the affected device was not returned.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.A few preoperative and postoperative radiographs were shared.Along with that an extensive medical record of the patient was also shared.Following that, these were shared to our hcp for a medical opinion.Strictly based on the information available, the medical opinion he shared was that the fracture/luxation was temporarily fixed with k-wires successfully and that there was no need for plates and screw.The luxation was fixed after a few weeks and then the material should be taken out to allow the normal function of the tarso-metatarsal joint.Even if the plate and screws were used, they should have been removed much earlier in a timely manner.Then one could see whether further residual symptoms remain.The luxation will-on the long term-lead to alterations and arthrosis in the tarso-metatarsal joints involved.He further opined that the pain is most likely related to the devices and he would recommend extracting them, as they no longer provide any function but only interferes with normal function in the tarso-metatarsal joint.Based on the medical records and hcp¿s medical opinion, the root cause of the failure is determined to be user and patient related, but predominantly user related.Although the pain is related to the device, but it is because of its prolonged stay inside the patient rather than any deficiency in itself.If any additional information is provided, the investigation will be reassessed.

Event Description

As reported: "lisfranc total dislocation.(b)(6) 2020 1st surgery k-wires were used to stabilize the foot.(b)(6) 2020 2nd surgery was performed orif where plate and 6 screws were used along with 2 k-wires.I have received physical therapy, use orthotics.Multiple x-rays there is pain through the foot and pain in side where plate is unable to move first 2 toes without using my hands.Times where i am unable to walk or put pressure on left foot".

• Brand Name: SLIM STRAIGHT PLATE, 3 HOLES (T8) VARIAX2 FOOT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10540884
• MDR Text Key: 207177974
• Report Number: 0008031020-2020-02232
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K170771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 626963
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 11/18/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 25 YR
• Patient Weight: 72