MAUDE Adverse Event Report: STRYKER GMBH M 3-D PROFILE PLATE, 3X2 HOLES; PLATE, FIXATION, BONE

Model Number	57-13121
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "on (b)(6) 2020, the patient was admitted to the hospital because of pain and poor activity in the right foot due to falling down.It was confirmed that 2 and 4 metatarsal of the right foot of the patient fractured.Then surgery was performed to the patient.After the surgery, the patient recovered and was discharged from the hospital.The patient went to the hospital for examination regularly.On (b)(6) 2022, the patient came to the hospital to remove the steel plate.The preoperative radiograph showed that the steel plate was broken, and the patient did not complain any obvious discomfort.The doctor thought that the bone healed well after examination, and agreed to remove the plate.The patient is in good condition after the surgery of removal of the plate.The event did not cause harm to the patient.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.
Additional Manufacturer Narrative
Please note the corrections to d1, d4 catalog #, d4 lot # and gtin.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.A review of the complaint history of catalog number 57-10191 has shown that there are no other complaints of the same nature registered.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint event.Based on the provided information was the device implanted for 19 months and the implant did fulfill its main function to support the bone healing process as required, although the device was used for the foot instead of the hand.However, both factors, the long implantation time and the region where the device was used, may have contributed to a fatigue failure of the plate.In this relation following statements of the instructions for use can be pointed out: ¿indications the variax hand implants are indicated for internal fixation of the bones of the hand for the following procedures: ¿fracture fixation ¿arthrodesis ¿deformity correction ¿reconstruction" [¿] "¿screw and plate implants are designed to function only until normal bone healing is completed (usually 6¿12 weeks).Delayed healing, non-union, bone resorption or additional trauma may lead to excessive stress on the implant(s) and result in loosening, bending, cracking or breaking of the implant(s)." if the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "on (b)(6)-2020, the patient was admitted to the hospital because of pain and poor activity in the right foot due to falling down.It was confirmed that 2 and 4 metatarsal of the right foot of the patient fractured.Then surgery was performed to the patient.After the surgery, the patient recovered and was discharged from the hospital.The patient went to the hospital for examination regularly.On (b)(6)2022, the patient came to the hospital to remove the steel plate.The preoperative radiograph showed that the steel plate was broken, and the patient did not complain any obvious discomfort.The doctor thought that the bone healed well after examination, and agreed to remove the plate.The patient is in good condition after the surgery of removal of the plate.The event did not cause harm to the patient.".

• Brand Name: M 3-D PROFILE PLATE, 3X2 HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15900416
• Report Number: 0008031020-2022-00667
• Device Sequence Number: 14728345
• Product Code: HRS
• UDI-Device Identifier: 04546540242877
• UDI-Public: 04546540242877
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 57-13121
• Device Catalogue Number: 57-10191
• Device Lot Number: 1000418304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown