MAUDE Adverse Event Report: STRYKER GMBH STRAIGHT PLATE VARIAX FIBULA, 7 HOLE / L96MM; PLATE, FIXATION, BONE

Model Number	40-20807S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	12/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "on (b)(6) 2020, the patient underwent the initial operation for forearm bone trunk with variax.Due to a nonunion, the patient underwent revision surgery with other company product on (b)(6) 2020.The surgeon requested to investigate whether there was a problem with the product itself.".
Event or Problem Description
As reported: "on (b)(6) 2020, the patient underwent the initial operation for forearm bone trunk with variax.Due to a nonunion, the patient underwent revision surgery with other company product on (b)(6) 2020.The surgeon requested to investigate whether there was a problem with the product itself.".
Additional Manufacturer Narrative
The reported event could partially be confirmed, since the device was returned and is broken, but no x-rays proving non union was returned.The plate turns out to be broken at the level of the 3rd locking hole.6 (4 locking, 2 non locking) screws were returned alongside the plate.No major damage was noticed in the screws.The plate identification (lot and catalog) could be confirmed.A microscope analysis was undertaken to inspect the breakage surface of the plate.The bridges were named as per the convention seen in the device inspection and will be examined more in details below.The analysis of bridge 1 shows a very smooth and shiny surface, which is specific to a fatigue fracture.Indeed, the analysis proves that the device broke at the level of bridge 1 first, most probably due to heightened mechanical loading following the reported delayed union.The metal of two opposites sides of the plate at the level of bridge 1 rubbed against one another for extended mechanical cycles, thus creating the smooth shiny surface we can see.The analysis of bridge 2 does not show the same shiny surface as seen in bridge 1.This proves that this bridge broke second, probably at once, due to the extended mechanical loading.Based on investigation, the root cause was attributed to a fatigue related issue.The failure was caused by extensive mechanical loading of the device when the bone was not fused yet.A review of the device history for the reported lot did not indicate any abnormalities.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: STRAIGHT PLATE VARIAX FIBULA, 7 HOLE / L96MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11164377
• Report Number: 0008031020-2021-00022
• Device Sequence Number: 3588588
• Product Code: HRS
• UDI-Device Identifier: 04546540667809
• UDI-Public: 04546540667809
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K102282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2014
• Device Model Number: 40-20807S
• Device Catalogue Number: 4020807S
• Device Lot Number: D25821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 04/26/2021
• 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