MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FIBULA PLATE, 5 HOLE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 40-20905

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/08/2022

Event Type  malfunction  

Event Description

It was reported that a surgery took place on (b)(6) 2022 due to the patient breaking their leg while riding a bicycle with his son.Follow up on the (b)(6) 2022 and patient took a picture of the x-rays.The screws are screwed into the plate but the plate is not screwed into the patient's bone.There is a gap between the patient's bone and the plate.Surgeon did not screw in screws all the away per what patient saw on the x-rays.When the patient asked the physician he mentioned that he used a locking screw and told the patient that it is no big deal.Patient is adamant about not notifying the physician involved of his inquiry into this event.He will be following up with another surgeon to seek another opinion.

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.

Event Description

It was reported that a surgery took place on 08-aug-2022 due to the patient breaking their leg while riding a bicycle with his son.Follow up on the (b)(6) 2022 and patient took a picture of the x-rays.The screws are screwed into the plate but the plate is not screwed into the patient's bone.There is a gap between the patient's bone and the plate.Surgeon did not screw in screws all the away per what patient saw on the x-rays.When the patient asked the physician he mentioned that he used a locking screw and told the patient that it is no big deal.Patient is adamant about not notifying the physician involved of his inquiry into this event.He will be following up with another surgeon to seek another opinion.

Manufacturer Narrative

The reported event could not be confirmed for the screws, all visible screws are in placed in the plate as required although there is a gap between the plate is visible on the received x-rays.The affected devices were not returned for evaluation, therefore no further investigation of the reported devices is possible.The complaint including patient questions was forwarded to medical affairs for review with following result: it can be said that satisfactory fracture healing is possible even with this plate positioning.The colleague is basically right when he says that the plate does not have to be in contact proximally.This is not absolutely necessary with angle-stable construct.The current position is not necessarily unacceptable and should therefore be adjusted.This depends on the further follow up and the upcoming x-ray.The image does show a persisting fracture gap, which is difficult to assess regarding the effect this may have for the upcoming healing.At the distal end of the plate as well as around the screws there seems to be some light zones within the surrounding bone which could be interpreted as a loosening area.However, with an interval of only one week between the operation and the control x-ray, the prognostic value is quite low.In general it can be mentioned that if we have notice, that a surgeon is using a stryker product wrong systematically we would reach out and try to support to improve the quality of care.This case can definitely not be assessed with the given information.It seems as if in this given case the relationship of trust between doctor and patient is permanently impaired.The patient should seek a second opinion by another surgeon in this case.We, as the manufacture cannot decide whether or not a surgical measurement is in need of revision (especially only with x-ray).A review of the device history was not possible because the lot number was not communicated.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.Based on the provided information, the root cause was attributed to a user related issue in regards to the placement of the implants.No product related issue could be detected.In this context following statements of the instructions for use can be pointed out: ¿responsibility for proper selection of patients, adequate training, experience in the choice and placement of implants and the decision to leave or remove implants postoperatively, rests with the surgeon.Responsibility for choosing where and how bones are repositioned rests with the surgeon.¿ if the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: DISTAL LATERAL FIBULA PLATE, 5 HOLE
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; postfach; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15473837
• MDR Text Key: 306255423
• Report Number: 0008031020-2022-00469
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 40-20905
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 11/22/2022
• Supplement Dates FDA Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 118 KG