MAUDE Adverse Event Report: STRYKER GMBH CURVED PLATE, 5 HOLES, RIGHT; PLATE, FIXATION, BONE

Model Number	40-15012
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	02/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; device remains implanted in patient.
Event or Problem Description
As reported: "believed to be fused and fully healed, but could possibly have to revise.Surgery was (b)(6) 2020, patient came in "last week" per dr.That had pain.Took x-ray.Broken.Scheduled to remove/possibly revise "soon", per dr.".
Event or Problem Description
As reported: "believed to be fused and fully healed, but could possibly have to revise.Surgery was on (b)(6) 2020, patient came in "last week" per dr.That had pain.Took x-ray.Broken.Scheduled to remove/possibly revise "soon", per dr.".
Additional Manufacturer Narrative
The reported event could be confirmed with the help of x-rays provided.The device inspection was not possible as the product was not returned for investigation.The device history 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.The instructions for use instructs user that: ¿screw and plate implants are designed to function only until normal bone healing is completed (usually 6-10 weeks).Delayed healing, non-union or subsequent bone resorption or trauma may lead to excessive stress on the implant(s) and result in loosening, bending, cracking or fracturing.¿ formal medical opinion was sought from an experienced independent medical expert as below: ¿the choice of the plate is fine, and the assisting cannulated screw looks correctly positioned.However, for the intended arthrodesis, the preparation of the bone and cartilage substance in the joint is decisive and this cannot be reliably assessed either in the x-ray or in the description.It is possible that insufficient preparation lead to prolonged time to union and consecutive plate breakage.There is still a fracture gap and it looks as if there was at most partial consolidation of the fusion.In both cases prolonged fusion and perhaps the development of a pseudarthrosis is the reason for the plate breakage.¿ based on investigation, the root cause was attributed to a patient related issue.The failure was caused due to prolonged fusion and perhaps the development of a pseudarthrosis.Ifu also states ¿delayed healing, non-union or subsequent bone resorption or trauma may lead to excessive stress on the implant(s) and result in loosening, bending, cracking or fracturing.¿ if device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: CURVED PLATE, 5 HOLES, RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11408194
• Report Number: 0008031020-2021-00077
• Device Sequence Number: 5723666
• Product Code: HRS
• UDI-Device Identifier: 07613154627806
• UDI-Public: 07613154627806
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K063875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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: 40-15012
• Device Catalogue Number: 40-15012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention