MAUDE Adverse Event Report: STRYKER GMBH SLIM STRAIGHT PLATE, 6 HOLES (T8) VARIAX 2 FOOT; PLATE, FIXATION, BONE

Model Number	587338RT
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented with pain in the right foot and in the implant.The patient had hardware removed due to mechanical failure/malfunction of fusion( right foot).The initial diagnosis was pseudarthrosis after fusion or arthrodesis.The pre-operative diagnosis was right hallux limitus with non-union.Non-union hallux interphalangeal joint fusion.The patient underwent revision right first metatarsal phalangeal joint fusion.Right foot hardware removal.Right hallux arthroplasty.Calcaneal bone graft harvesting.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the patient presented with pain in the right foot and in the implant.The patient had hardware removed due to mechanical failure/malfunction of fusion( right foot).The initial diagnosis was pseudarthrosis after fusion or arthrodesis.The pre-operative diagnosis was right hallux limitus with non-union.Non-union hallux interphalangeal joint fusion.The patient underwent revision right first metatarsal phalangeal joint fusion.Right foot hardware removal.Right hallux arthroplasty.Calcaneal bone graft harvesting.
Additional Manufacturer Narrative
The reported event could be confirmed, since the plate is broken apart as complained.The device inspection revealed the following: one (1) plate together with seven (7) was returned for evaluation.The plate is broken apart and does belong to the legacy stryker variax 2 foot system.Three (3) of the returned screws belong to the variax 2 system.The other four (4) screw belong most likely to the legacy wright medical cannulated screw system (css).The evaluation of these devices will be performed under the complaints (b)(4), (b)(4), (b)(4) and (b)(4).The visual inspection has shown that the plate is broken apart at one of the two center holes.The catalog- and lot number of the device can be confirmed based on the laser markings.There is compressed material visible at the fracture zones, this indicates that the fragments rubbed against each other under high pressure after the breakage.At four (4) plate holes are damages visible, this indicates that these holes were occupied with a screw.There was no information provided how the returned screws were used, fact is that only three (3) screws of the variax 2 system were returned.The microscopic evaluation has shown that the fractures faces are almost not present anymore.The fracture surface is totally flattened, which also indicates that the fragments rubbed against each other under high pressure after the breakage for a longer period of time.The remainders of the fracture face have the typical view of a fatigue fracture with an uniform fine-grained texture.The relevant dimensions of the plate were verified during the investigation and no deviation from the specification could be detected.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.No product related issue could be detected.There was no additional information about the event provided, it is unknown how long the implants were implanted, no x-rays and no information about the patient history/activity was provided.In addition, it is unknown how the returned implants from different systems are related to each other.Therefore the root cause of the reported non-union and of the breakage cannot be defined.The evaluation of the plate has shown that fatigue, most likely caused by the non-union, did lead to the breakage of the device.In this relation following statement from the variax 2 foot system instructions for use can be pointed out: "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." if more information is provided, the case will be reassessed.

• Brand Name: SLIM STRAIGHT PLATE, 6 HOLES (T8) VARIAX 2 FOOT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach TN 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach TN 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16362677
• Report Number: 3010667733-2023-00065
• Device Sequence Number: 17845968
• Product Code: HRS
• UDI-Device Identifier: 07613327170863
• UDI-Public: 07613327170863
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2023

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: 587338RT
• Device Catalogue Number: 626966
• Device Lot Number: H65708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2021
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic