MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN TITANIUM SCREW; PLATE, FIXATION, BONE

Catalog Number UNK_SEL

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Loss of Range of Motion (2032); Implant Pain (4561)

Event Date 09/26/2022

Event Type  Injury  

Event Description

It was reported that the patient had a knee replacement in about 2013 and patient had no issue with that.The patient fell on (b)(6) 2021 and was sent to urgent care and they witnessed no issues on imaging.Further imaging was done by the patient's surgeon's and they identified a patella fracture for which the patient received two titanium screws.Patient was completing physical therapy but was experiencing pain and an x-ray confirmed that the screws were fractured.Range of motion is limited.Patient is in pain when walking.Patient will be meeting with a surgeon from wv university orthopedics to find out the best path forward for treatment.

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.Device remains implanted in patient.

Event Description

It was reported that the patient had a knee replacement in about 2013 and patient had no issue with that.The patient fell on (b)(6) 2021 and was sent to urgent care and they witnessed no issues on imaging.Further imaging was done by the patient's surgeon's and they identified a patella fracture for which the patient received two titanium screws.Patient was completing physical therapy but was experiencing pain and an x-ray confirmed that the screws were fractured.Range of motion is limited.Patient is in pain when walking.Patient will be meeting with a surgeon from wv university orthopedics to find out the best path forward for treatment.

Manufacturer Narrative

Please note the correction to h6 results code.The reported event could be confirmed, since one of the two visible screws on the received x-rays is broken apart.A device inspection was not possible since the affected device was not returned.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.The catalog number and lot number were not communicated.The available information and the received x-rays were compared with different stryker screw systems including asnis iii and fixos, which are typical standalone screws.The review has shown that the screws on the x-ray could be a variax 2 bone screw, t10 full thread, 2.7mm.There are slight differences in the head shape visible, but this can be traced back to the quality of the x-ray and the insertion angle of the screw.However, it can finally also not be completely excluded that the visible bone screw is from a competitor as such bone screws belong to the standard portfolio of a medical device manufacturer.A review of the potentially affected variax 2 labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.The complaint was forwarded to medical affairs for review with following result: "in my opinion from the sent x-ray i can only confirm one breakage for sure.The other screw looks intact.Although reading through the added patient history, it is not 100% clear to me what has happened.There is information in it, that the initial joint replacement included a patella component.That seems to have loosened¿there is a meeting minute with the patient that the doctor informed the patient on two potential treatment options.1.Replacement of the component; 2.Patellectomy.This third potential treatment was not mentioned before.Is it a iatrogenic fracture while explantation of the old component? whatever the cause is¿.If we have a fracture here, an attempt for fracture treatment could be made with screws.The orientation of the screws suggests, that there was a longitudinal fracture of the patella.It could also have been complex with the chosen combination of k-wires and screws.However, the only fracture that can be addressed sufficiently with screws-k-wires only is a longitudinal one.Otherwise it would require a tension bend wiring and usually one would add a circumferential cerclage around the patella to prevent secondary displacement." finally, more detailed information, including catalog- and lot number, about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.In general following statements related to implant breakage of the variax 2 instructions for use can be pointed out: ¿adverse events and adverse effects in many instances, adverse results may be clinically related rather than device related.The following are the most frequent adverse effects involving the use of internal fracture fixation devices: delayed union or non-union of the fracture site.These devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device.Conditions attributable to non-union, osteoporosis, osteomalacia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.Improper alignment can cause a mal-union of the bone and/or bending, cracking or even breakage of the device.¿ if the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: UNKNOWN TITANIUM SCREW
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15637565
• MDR Text Key: 302056817
• Report Number: 0008031020-2022-00551
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/04/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/20/2022
• Supplement Dates Manufacturer Received: 12/07/2022
• Supplement Dates FDA Received: 01/04/2023
• 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 Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 84 KG